Exhibit A

Case 2:15-md-02641-DGC Document 9864-1 Filed 01/26/18 Page 1 of 14
r~, 

t,· ~J DEPARTMENT OF HEALTH AND HUMAN SERVICES __ --::---:--____ ~_:_:__. ~ Food and Drug Administration 

Los Angeles District 

Pacific Region 

WARNING LETTER 

VIA UNITED PARCEL SERVICE 

SIGNATURE REQUIRED 

July 13,2015 

Timothy M. Ring 

Chainnan and Chief Executive Officer 

C.R. Bard Inc. 

730 Central Ave. 

Murray Hill, NJ 07974 

Dear Mr. Ring: 

19701 Fairchild 

Irvine, CA 92612 

Telephone: 949-608·2900 

Fax: 949-6084415 

WIL # 27-15 

During inspection of your C.R. Bard Inc. facility located at 289 Bay Rd, Queensbury, NY, on 

October 6, 2014, through November 25, 2014, and during inspection of your Bard Peripheral 

Vascular facility located at 1625 W. 3rd St., Tempe, AZ, on November 18,2014, through January 

05,2015, investigators from the United States Food and Drug Administration (FDA) determined 

that your finn is a specification developer and manufacturer for the Inferior Vena Cava (lVC) 

filter delivery systems and components, including, but not limited to, the Denali Filter, the Simon 

Nitinol Filter and Recovery Cone Removal Kit. This warning letter addresses violations found 

at the Bard Peripheral Vascular facility located at 1625 W. 3rd St., Tempe, AZ and C.R. Bard Inc. 

facility located at 289 Bay Rd, Queensbury, NY. Under section 201(h) of the Federal Food, 

Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they 

are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, 

treatment, or prevention of disease, or is intended to affect the structure or any function of the 

body. 

We received responses dated December 17,2014, January 15, 2015, February 18,2015, March 

16, 2015, April 17, 2015, and May 6, 2015, from Mr. Jason J. Gaede, Vice President Plant 

Operations, C.R. Bard Inc., Queensbury, NY. We also received responses dated January 26, 

2015, February 26, 2015, March 26, 2015, April 24, 2015, and May 22, 1015, from Steve S. 

Williamson. President, Bard Peripheral Vascular, a Division of C.R. Bard, Tempe, AZ. These 

were responses to the observations noted on Form FDA 483s, Lists of Inspectional Observations 

that were issued to you at the close of our inspections. We address your responses below, in 

relation to each of the noted violations. These violations include, but are not liniited to, the 

. following: 

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AdulterationlMisbranding Violations at the Tempe, AZ facility 

I. FDA has learned that your fInn manufactures the Recovery Cone Removal System, 

Model RC-15 in the United States without marketing clearance or approval, in violation 

of the Act. Under section 201 (h) of the Act, 21 U.S.C. § 321(h), this product is a device 

because it is intended for use in the diagnosis of disease or other conditions or in the cure, 

mitigation, treatment, or prevention of disease, or is intended to affect the structure or any 

function of the body. As explained below, this device is being marketed without the 

required clearance or approvaL 

The Recovery Cone Removal System, Model RC-15 is adulterated under section 

501(f)(I)(B) of the Act, 21 U.S.C. § 351(f)(l)(B), because you do not have an approved 

application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 

21 U.S.C. § 360e(a), or an approved application for an investigational device exemption 

(IDE) under section 520(g) ofthe Act, 21 U.S.C. § 360j(g). The Recovery Cone Removal 

System, Model RC-15 is also misbranded under section 502(0) the Act, 21 U.S.c. § 

352(0), because you did not notify the agency of your intent to introduce the device into 

commercial distribution, as required by section 51O(k) of the Act, 21 U.S.C. § 360(k). 

FDA reviewed labeling for the Recovery Cone Removal System, Model RC-15, which 

revealed that this device is intended to percutaneously remove the Recovery Filter, 

Recovery 02 Filter and the 02X Filter as indicated. FDA is aware that your firm 

submitted both in-vitro and in-vivo testing demonstrating the use of the Recovery Cone 

Removal System, Model RC-15 for removal of the Recovery Filter (K031328), the G2X 

Filter (K0823 05), the 02 Express Filter (K080668), and the G2 Filter (K073 090). 

However, the Recovery Cone System, Model RC-15 was not included as part of the 

clearances for any of the aforementioned IVC filters. Therefore, your finn is marketing 

the Recovery Cone Removal System, Model RC-15 in the United States without 

marketing clearance or approval. Percutaneous retrieval systems, such as the Recovery 

Cone Removal System, Model RC-15, are regulated as manual surgical instruments 

intended for specialized use within a specific medical specialty, and thus reqUIre 

marketing authorization in order to be legally marketed in the United States. 

Your fIrm has not submitted any correspondence to FDA regarding this violation to date. 

2. FDA has also learned that your firm manufactures the Recovery Cone Removal System, 

Model FBRC in the United States without marketing clearance or approval, in violation 

of the Act. Under section 201(h) of the Act, 21 U.S.C. § 321 (h), this product is a device 

because it is intended for use in the diagnosis of disease or other conditions or in the cure, 

mitigation, treatment, or prevention of disease, or intended to affect the structure or any 

function of the body. As explained below, this device is being marketed without the 

required clearance or approval. 

The Recovery Cone Removal System, Model FBRC is adulterated under section 

501(f)(l)(B) of the Act, 21 U.S.C. § 351(f)(l)(B), because you do not have an approved 

, , 

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application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 

21 U.S.C. § 360e(a), or an approved application for an investigational device exemption 

(IDE) under section 520(g) of the Act, 21 V.S.c. § 360j(g) for the device as described 

and marketed. The Recovery Cone Removal System, Model PBRC is also misbranded 

under section 502(0) the Act, 21 U.S.C. 352(0), because you introduced or delivered into 

interstate commerce for commercial distribution a device with major 

changes/modifications to the intended use without submitting a new premarket 

notification to the agency as required by section 51O(k), 21· U.S.C. 360(k), and 21 c.P.R. 

807.8 1 (a)(3)(ii). 

You have listed the Recovery Cone Removal System, Model FBRC as a class I surgical 

snare under 21 CFR 878.4800. Devices classified under 21 CPR 878.4800 (Surgical 

Instrument, Manual) are exempt from premarket notification, unless they exceed the 

limitations on exemptions at 21 CFR 878.9(a). However, there is evidence that the 

Recovery Cone Removal System, Model FBRC is intended for uses that are different 

from those of legally marketed devices under 21 CFR 878.4800 (Surgical Instrument, 

Manual). Devices of this type usually consist of a non-powered, hand-held, or handmanipulated device that is either reusable or disposable, which are intended to be used in 

general surgical procedures. Manual surgical instruments intended for specialized uses . 

within a specific medical specialty are classified under regulations separate from 21 CFR 

878.4800, depending on the labeled specialized use of the device. However, your firm is 

marketing the Recovery Cone Removal System, Model FBRC for a specialized intended 

use, namely percutaneous removal of inferior vena cava filters, specifically your firm's 

G2X Filter, G2 Express Filter, and G2 Filter. The labeling for the Recovery Cone 

Removal System, Model FBRC also indicates that your product is intended to 

percutaneously remove a foreign body. 

Based on the above, FDA believes that the Recovery Cone Removal System, Model 

FBRC is regulated as a percutaneous retrieval system, which is a manual surgical 

instrument intended for specialized use within a specific medical specialty, 

cardiovascular surgery. Because there is evidence that the Recovery Cone Removal 

System, Model FBRC is intended for uses that are different from those of legally 

marketed devices classified under 21 CFR 878.4800, it exceeds the limitations described 

in 21 C.F.R. 878.9(a) and is not exempt from premarket notification. 

Your finn has not submitted any correspondence to the FDA regarding this violation to date. 

F or a device requiring premarket approval, the notification required by section 510(k) of the Act, 

21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. 

807 .81 (b). The kind of infonnation you need to submit in order to obtain approval or clearance 

for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. 

The PDA will evaluate the information you submit and decide whether your product may be 

legally marketed. 

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FDA requests that Bard Peripheral Vascular immediately cease activities that result in the 

misbranding or adulteration of the Recovery Cone Removal System, Model RC-I5 and the 

Recovery Cone Removal System, Model FBRC, such as the commercial distribution of the 

devices for the uses discussed above. 

Quality System Violations 

The inspections also revealed that these devices are adulterated within the meaning of section 

SOI(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls 

used for, their manufacture, packing, storage, or installation are not in confonnity with the 

current good manufacturing practice requirements of the Quality System regulation found at 

Title 21, Code of Federal Regulations (CFR), Part 820. 

The inspection of your Bard Peripheral Vascular Facility located at 1625 W. 3rd St., Tempe, AZ 

also revealed that the lVC Denali Filter Delivery System is misbranded under Section 502(t)(2) 

of the Act, 21 U.S.c. § 352(t)(2), in that your firm failed or refused to furnish material or 

information regarding the devices that is required by or under Section 519 of the Act, 21 U.S.C. 

§ 360i, and 21 CFR Part 803 - Medical Device Reporting. 

Quality System Regulation Violations at the Tempe, AZ facility and Queensbury, NY 

facility 

3. Failure to establish and maintain procedures for receiving, reviewing, and evaluating 

complaints as required by 21 CFR 820. 198(a). Your current procedures governing 

complaint investigation activities at your facilities, CQA-STD-24 Standard for Product 

Complaint Handling Rev. 11 and CQA-STD-55, Standard for Complaint Investigation 

Process Rev. 01, MP9113, Complaint Investigation Actjvity Rev. 40, SOPQOI53100, 

BPV Complaint Handling System, Rev. 18, and SOPQ0700200, Complaint Investigation 

Procedures, Rev. 15 do not ensure product complaints are adequately evaluated. For 

example: 

a. Your current procedures governing complaint investigation activjties, CQA-STD24 Standard for Product Complaint Handling Rev. 11, CQA-STD-55, Standard 

for Complaint Investigation Process Rev. 01, MP9113, Complaint Investigation 

Activity Rev. 40, SOPQ0153100, BPV Complaint Handling System, Rev. 18, and 

SOPQ0700200, Complaint Investigation Procedures, Rev. 15 do not include 

adequate instructions for ensuring that complaints involving a device or device 

component provided by a supplier are adequately evaluated for root cause of the 

alleged device failure and that appropriate corrective action is implemented with 

your suppliers. 

b. Complaint 562535 for a G2 Filter, embolization of a detached filter arm with 

associated areas of hemorrhage and necrosis in the right lung was filed as a 

malfunction Medical Device Report [MDR] and should have been filed as a 

death. The following complaints were filed as malfunctions and should have been 

filed as serious injuries: Complaint 628924, Eclipse Filter, detached filter limb 

resulting in pericardial effusion and cardiac catheterization; 574429, G2 Express 

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Filter, broken filter and surgical intervention; 602904, Denali Jugular System, 

detached filter arm embedded in Ive wall with filter retrieval; 443237, G2 Filter, 

detached filter limb in renal vein with rvc wall perforation and blood thinner 

treatment; 446809, G2 Express Filter, IVe perforation and aneurysm; 454485, G2 

Filter, abdominal pain with filter legs protruding through Ive wall and 

percutaneous removal; 562566, G2 Filter, abdominal pain with filter legs 

perforating IVe wall, partial retrieval and residual filter leg fragment embedded 

in rve wall. 

c. Complaints 507112, 507109, 507115, 507252, 507280, 507302, 507311 and 

507325 report at least io patients who were exposed to scheduled retrieval 

surgical procedures to remove an IVC filter that were not successful. However, 

these complaint files do not document sufficient information to allow for adequate 

complaint investigation and disposition, including, but not limited to, MDR 

determination. For example, the complaints do not include information regarding 

prolonged or repeated surgery that may have occurred as a result of failed 

attempts to remove the filters, information regarding why the filters were 

scheduled to be removed and potential complications related to leaving them in 

the patient due to failed removal, and/or if any additional drugs or anesthetics had 

to be supplied to the patients. 

We find that your responses dated December 17, 2014, January 15, 2015, February 18, 2015, 

March 16,2015, April 17,2015 and May 6, 2015 from Mr. Jason J. Gaede, Vice President Plant 

Operations, C.R. Bard Inc., Queensbury, NY and your responses dated January 26, 2015, 

February 26, 2015, March 26, 2015, April 24, 2015, and May 22, 2015, from Mr. Steve S. 

Williamson, President, Bard Peripheral Vascular, a Division of C.R. Bard, Tempe, AZ do not 

adequately address these deficiencies. For example, your January 26, 2015, response states that 

you made clerical errors and that you opened a CAP A to track training and determination of foot 

cause with corrective and preventive actions. Your response is inadequate and does not assure 

that your complaint handling system reviews and evaluates complaints adequately. Additionally, 

the revised complaint procedures provided with your initial responses do not include adequate 

corrections to complaint investigation procedures with regards to the above stated deficiencies. 

Your follow-up responses do not address any corrections for complaint handling deficiencies. 

Your responses also state that all actions have been implemented with respect to the violation 

and that your finn considers your response to be complete. 

Quality System Regulation Violations at the Queensbury, NY facility 

4. Failure to validate) with a high degree of assurance and approve according to established 

procedures, a· manufacturing process that cannot be fully verified by subsequent 

inspection and testing, to ensure the process will continue to meet specifications as 

required by 21 CFR 820.75(a). 

a. Specifically, lVC filter cleaning, to include removal of chemical processing 

contaminants, has not been validated for IVC Filters to include Simon Nitinol 

Filters, Eclipse Filters and Denali Filters. For example, production of Dellflli 

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Filters requires the use of several processing agents, including, but not limited to 

the following: nitric acid, methanol, sulfamic acid solution, thermo quench salt, 

glycolic acid, citric acid, and/or hydrofluric acid. The cleaning processes for IVC 

filters are not validated or otherwise verified to demonstrate that the above 

substances are reduced to acceptable levels during routine processing under worst 

case conditions. Therefore, your manufacturing process was not validated with 

a high degree of assurance and approved according to established procedures, nor 

were the process results fully verified by subsequent inspection and test, as 21 

CFR 820.75(a) requires. 

b. Your finn's own Process Qualification (PQ) Final Report PRTI0-064 Rev A., 

dated May 29, 2013, states that a 100% inspection plan is necessary for all failed 

predefined acceptance criteria during process validation. In particular, the PQ 

Final Report defines process capability acceptance criteria for Denali Filter . Part 

#RM5109000 dimensions of C, D, L, M, G, N, W, F, T, U and the radial force 

functional test to be a CpK greater than or equal to 1.33 as a requirement to 

validate the process. Your process qualification failed to meet this predefined 

acceptance criteria for these filter dimensions and functional test. Therefore, 

according to your own manufacturing process validation document, 100% 

inspection for verification of these specifications on each lot of product is 

required to mitigate your failed process validation. However, your firm has not 

ensured 100% inspection of dimensions N, Vi, F, G and M, which lacked 

validation. Your firm has also not conducted adequate subsequent process 

validation studies to eliminate this requirement. As a result, your manufacturing 

process was not validated with a high degree of assurance and approved according 

to established procedures, nor were the process results fully verified by 

subsequent inspection and test, as 21 CPR 820.75(a) requires. 

We find that your responses dated December 17, 2014, January 15, 2015, February 18, 2015, 

March 16,2015, April 17, 2015, and May 6,2015, are not adequate for the following reasons: 

• With regard to your promised corrections for IVC filter cleaning lacking process 

validation, we find your response partially adequate. We acknowledge your firm's 

actions to date associated with the CAPA you opened in response to this observation, GFCAP A-IS-002. We acknowledge that you reviewed 510K submission data for the Denali 

Filters, conducted recent cytotoxicity testing for Denali Filters and revised your Process 

Validation procedure, SOP 820.100.6, Rev 43., to specifically include the requirement of 

validating cleaning processes for components or devices that undergo contact with 

processing agents. We acknowledge your progress to date validating. the cleaning 

processes for Denali Filters manufactured by both of your suppliers and Simon Nitinol 

Filters; however, this data will need further review during a follow-up inspection to 

verify adequacy of actions taken. We also acknowledge your performance of exhaustive 

extraction testing for the Denali Filters manufactured by one of your suppliers; however, 

the other supplier of these filters uses a different manufacturing process, processing 

agents, and equipment. Because of these differences, we recommend that you perform 

exhaustive extraction testing for Denali Filters manufactured by this supplier to ensure no 

residuals are present on these devices. Additionally, your fum has stated it is no longer 

manufacturing the Eclipse Filters as of 9/8/14; however, your firm has not indicated plans 

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regarding the stored inventory of these devices and continues to market them in the 

United States. Your response to date does not indicate corrective action for these devices 

that may still be in inventory and/or may still be distributed. 

e With regard to your promised corrections relating to process validation of your Denali 

Filter Part #RM5I09000 dimensions ofF, N, W, G and M, we find that your response is 

not adequate. Your Process Qualification (PQ) Final Report PRTlO-064 Rev A., dated 

May 29, 2013, states that a 100% inspection plan is necessary for all failed predefmed 

acceptance criteria during process validation. In particular, the PQ Final Report defmes 

process capability acceptance criteria for Denali Filter Part #RM5109000 dimensions 

and/or functional tests of C, D, L, M, G, N, W, F, T, U and Radial Force to be a CpK 

greater thim or equal to 1.33 as a requirement to validate the process. This predefined 

acceptance criterion was not met. Consequently; your firm conducted a retrospective 

analysis to change this original process validation criterion. You state your firm 

retrospectively analyzed data and determined that dimensions N and W may stay on AQL 

0.65 limited inspections because the analysis demonstrated a 95/99.9% confidence. level. 

However, your rationale for changing the original process validation acceptance criterion 

for dimensions N and W is not adequately supported. 

Further, you have not been successful at validating the manufacturing process with respect to 

dimensions F, G and M, which failed predefmed acceptance criteria. Your firm has not 

provided adequate data to support that these dimensions have been 100% inspected for every 

lot of product manufactured, as required by your firm's own manufacturing process 

validation document, PQ Final Report PRTIO-064. And lastly, the corrective actions 

proposed as part of CAPA GF-CAPA-15-001 are in progress, and will need verification of 

implementation upon completion during a future inspection. For these reasons; your 

responses dated December 17, 2014, January 15, 2015, February 18, 2015, March 16,2015, 

April 17, 2015, and May 6; 2015, are inadequate. 

5. Failure to establish and maintain procedures for acceptance of incoming product and to 

inspect, test or otherwise verify incoming product as conforming to specified 

requirements as required by 21 CFR 820.80(b). 

Specifically, based on your Process Qualification (PQ) Final Report PRTI0-064 Rev A., 

dated May 29,2013, process capability acceptance criteria of CpK greater than or equal 

to 1.33 for Denali Filter Part #RM51 09000 dimensions C, D, L, M, G, N, W, F, T, U and 

the radial force functional test were not met. As a result, these dimensions and/or 

functional tests were to remain on a 100% inspection plan during manufacture at your 

supplier in order to be accepted into inventory. However, your finn accepted supplier lot 

numbers #33511-39, #33511-42, #33511-43, #33511-44, #33511-45, #33511-46, 

#33511-47, #33511-48, #33511-49, #33511-50, #33511-51, #33511-53, #33595-2A-20, 

#33595-2A-27, #33595-2A-29, #33595-2A-31, #33595-2A-30, #33595-2A-33, #33595-

2A-35, #33595-2A-39, #33595-2A-40, #33595-4, and #33771-112 of Denali Filter Part 

#RM5109000, which your supplier inspected with an AQL 0.65 sampling plan for 

dimensions N; W, P, G; and M, rather than 100% inspection. Your firm. also accepted 

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supplier lot numbers #33771~129 and #34360-24 of Denali Filter Part #RM5109000, 

inspected by your supplier with an AQL 0.65 sampling plan for dimensions N and W, 

rather than 100% inspection. Your procedures for acceptance of incoming product, 

including Inspection Plan IP #1450935 Rev. 2., were not adequately established and 

maintained to verify that incoming product conformed to your specified requirements of 

100% inspection plan for dimensions N, W, F, G, and M. As a result, you failed to 

inspect, test or otherwise verify incoming product as conforming to your specified 

acceptance requirements, as required by 21 CFR 820.80(b). 

We find your responses dated December 17, 2014, January 15, 2015, February 18, 2015, 

March 16,2015, April 17, 2015, and May 6,2015, partially adequate. Your responses do not 

clarifY whether acceptable corrective actions have been taken with the above stated lots of 

Denali Filter components that lacked 100% inspection of dimensions N, W, F, G, and M to 

ensure your specified acceptance requirements have been met for these accepted lots. Your 

response does not contain evidence that the above stated lots indicating an AQL 0.65 

sampling plan for dimensions F, G and M were in fact inspected at 100% for F, G and M. 

Further, your response does not contain evidence that your supplier's AQL 0.65 sampl~ng 

plan is an adequate inspection, test, or verification of incoming product for dimensions N and 

W. We acknowledge your firm has opened CAPA GF-CAPA-15-005 to address systemic 

corrections to this observation; however, outputs of this CAP A are still in progress and will 

need to be verified during an FDA inspection of your firm. 

6. Failure to establish and maintain procedures to ensure that all purchased or otherwise 

received product and services conform to specified requirements, as required by 21 CFR 

820.50. In particular, 21 CFR 820.50(a) requires that each manufacturer establish and 

maintain requirements, including quality requirements, that must be met by suppliers, 

contractors, and consultants. 

Specifically, your Process Qualification (PQ) Final Report PRTI0-064 Rev A., dated 

May 29,2013, documented that process capabilities for filter dimensions C, D, L, M, G, 

N, W, F, T, U and the functional test radial force, as defined under section 7 Acceptance 

Criteria - Process Qualification of this report, were not met for all dimensions and 

functional tests. The PQ Final Report states that because the process capabilities were 

not met, these filter dimensions and functional test should remain on a 100% inspection 

plan at your supplier until su~h time that objective evidence indicates process capability 

has been demonstrated. However, your supplier failed to inspect the product on a 100% 

inspection plan for filter dimensions N, W, F, G and M, and process capability was not 

demonstrated through objective evidence. For example, from approximately May 11, 

2013 to August 5, 2013, your supplier of Denali Filter Part #RM5109000 provided you 

with a Certificate of Compliance for supplier lot numbers #33511-39, #33511-42, 

#33511-43, #33511-44, #33511-45, #33511-46, #33511-47, #33511-48, #33511-49, 

#33511-50, #33511-51, #33511-53, #33595-2A-20, #33595-2A-27, #33595-2A-29, 

#33595-2A-31, #33595-2A-30, #33595-2A-33, #33595-2A-35, #33595-2A-39, #33595-

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2A-40, #33595-4, and #33771-112. These certificates documented the supplier did not 

conduct 100% inspection for filter dimensions N, W, F, G and M. Your firm did not 

begin to address the issue with your supplier until approximately August 5, 2013 during 

an audit of your supplier, which was after most of these 23 lots were accepted into your 

inventory and used.in the manufacture of finished Denali IVC Filter devices. 

In the PQ Final. Report PRTIO-064 Rev A., your :firm establishes purchasing control 

procedures as required by 21 CFR 820.50(a). These procedures include continued 100% 

inspection by your supplier for process capabilities that were not met with regards to 

filter dimensions C, D, L. M, G, N, W, F, T, U and for process capabilities that were not 

met with respect to the functional test radial force. However, when filter dimensions N, 

W, F, G, and M failed your established process capabilities, your supplier did not conduct 

100% inspection. By failing to maintain adequate supplier control procedures (i.e., by 

failing to ensure 100% inspection was conducted for failed process capabilities), your 

firm violated 21 CFR 820.50(a), which requires that manufacturers establish and 

maintain requirements that must be met by suppliers. 

Additionally, when suppliers are placed on Limited Approved status, such as your 

supplier of the Denali Filter Part #RM5109000. Norman Noble Inc., you do not have 

adequate instructions in your supplier control procedures, including but not limited to 

CQA-STA-18 Supplier Performance Management Rev. OS, to re-evaluate suppliers to 

ensure that the supplier is better able to meet your specifications. 

We find that your responses December 17,2014, January 15,2015, February 18,2015, March 

16, 2015, April 17, 2015, and May 6, 2015, appear adequate, but are still in progress and will 

need to be verified during an FDA inspection of your finn. 

MDR Violations at the Tempe, AZ facility 

Our inspection of your Bard Peripheral Vascular facility located at 1625 W.3rd St., Tempe, AZ 

also -revealed that the Cardiovascular intravascular filter, (lVe Denali Filter Delivery System), is 

misbranded under Section 502(t)(2) of the Act, 21 U.S.c. § 352(t)(2), in that your firm failed or 

refused to furnish material or information regarding the devices that is required by or under 

Section 519 of the Act, 21 U.S.C. § 360i, and 21 CPR Part 803 - Medical Device Reporting. 

Significant deviations include, but are not limited to: 

7. Failure to submit a report to FDA no later than 30 calendar days after the day that your 

finn received or otherwise became aware of information, from any source, that 

reasonably suggests that a device that your firm markets has malfunctioned and this 

device or a similar device that your finn markets would be likely to cause or contribute to 

a death or serious injury, if the malfunction were to recur, as required by 21 CFR 

803.50(a)(2). 

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For example, Complaint numbers 574292, 427438, 418704, and 416808 describe a 

malfunction of your firm's device, which is classified as a long term implant. Your finn 

did not rule out that the reported malfunctions would not be likely to cause or contribute 

to a death or serious injury, if it were to recur. Therefore, an MDR should have been 

submitted for each of the referenced complaints. 

We reviewed your finn's responses received by the FDA, including the January 26, 2015, 

response, and conclude the response is not adequate. Your firm did not submit MDRs for the 

above referenced complaints and failed to justify why such malfimctions would not be likely to 

cause or contribute to a death or serious injury, if the malfunctions were to recur. 

8. Failure to obtain and submit to the FDA information that is incomplete or missing from 

reports submitted by user facilities, importers, and other initial reporters; and if unable to 

submit complete information on a report, failure to provide a statement in your firm's 

report explaining why required information was incomplete and the steps taken by your 

firm to obtain the information, as required by 21 CFR 803.50(b)(2) and 21 CFR 

803.50(b)(3). 

Specifically, your firm submitted 15 MDRs to the FDA, which did not identify the 

patient's "Age at Time of Event" or "Date of Birth" in Blocks A2 and A4, respectively, 

of the FDA Form 3500A. In addition, your firm did not include an explanation of why 

the required information was not provided and the steps taken to obtain such information. 

We reviewed your firm's responses received by the FDA, including the January 26, 2015, 

response, and conclude the response is not adequate. Although the FDA has received 

supplement reports for some of the MDRs, we have not received supplements for all. 

The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical 

Device Reports (eMDRs) to FDA was published on February 13,2014. The requirements of this 

final rule will take effect on August 14, 2015. If your firm is not currently submitting reports 

electronically, we encourage you to visit the following web link for additional information about 

the electronic reporting requirements: 

http://www.fda.gov/ForlndustryIFDAeSubmitter/ucmI07903.htm 

If your firm wishes to discuss MDR Reportability criteria or to schedule further communications, 

it may contact the Reportability Review Team by email at: 

ReportabilityReviewTeam@fda.hhs.gov 

Your finn should take prompt action to correct the violations addressed in this letter. Failure to 

promptly correct these violations may result in regulatory action being initiated by the FDA 

without further notice. These actions include, but are not limited to, seizure, injunction, and civil 

money penalties. Also, federal agencies may be advised of the issuance of Warning Letters 

about devices so that they may take this information into account when considering the award of 

contracts. Additionally, premarket approval applications for Class III devices to which the Quality 

B PV-17 -01-00204240 

Case 2:15-md-02641-DGC Document 9864-1 Filed 01/26/18 Page 11 of 14
C.R Bard Inc. 

Page 12 

~ f.- , Alonza E. ruse, Director 

'L-o{ Angele District 

Cc: 

Kevin J. Bovee 

Director of Quality AssUrance 

C.R. Bard, Inc. 

289 Bay Road 

Queensbury, NY 12804 

Jason J. Gaede 

Vice President, Plant Operations 

C.R. Bard, Inc. 

289 Bay Road 

Queensbury, NY 12804 

Mark M. Walaska 

Staff Vice President Manufacturing 

Bard Peripheral Vascular, Inc. 

1625 W. 3rd S1. 

Tempe, AZ 85281 

Steve S. Williamson 

President 

Bard Peripheral Vascular, Inc. 

1625 W. 3rd St. 

Tempe, AZ 85281 

Patricia Christian 

Vice President, Quality, Regulatory and Medical Affairs 

C.R. Bard, Inc. 

730 Central Ave. 

Murray Hill, NJ 07974 

Gin Schulz 

Vice President, Corporate Quality Assurance 

C.R. Bard, Inc. 

730 Central Ave. 

Murray Hill, NJ 07974 

BPV-17-01-00204241 

Case 2:15-md-02641-DGC Document 9864-1 Filed 01/26/18 Page 12 of 14
C.R. Bard Inc. 

Page 11 

System regulation violations are reasonably related will not be approved until the violations have 

been corrected. Requests for Certificates to Foreign Governments will not be granted until the 

violations related to the subject devices have been corrected. 

Please notify this office in writing withiri fifteen (15) business days from the date you receive 

this letter of the specific steps your finn has taken to correct the noted violations, as well as an 

explanation qf how your firm plans to prevent these violations, or similar violations, from 

occurring again. Include documentation of the corrections andlor corrective actions (including 

any systemic corrective actions) that your firm has taken. If your finn's planned corrections 

andlor corrective actions will occur over time, please include a timetable for implementation of 

those activities. If corrections andlor corrective actions cannot be completed within fifteen (15) 

business days, state the reason for the delay and the time within which these activities will be 

completed. Your firm's response should be comprehensive and address all violations included in 

this Warning Letter. 

Your written response should be sent to the Food and Drug Administration; Attention: 

Dr. Raymond W. Brullo 

Compliance Officer, Los Angeles District 

U. S. Food and Drug Administration 

19701 Fairchild 

Irvine, CA 92612 

A copy of your written response should also be sent to: 

LCDR Catherine M. Beer 

Compliance Officer 

U. S. Food and Drug Administration 

One Winners Circle, Suite 110 

Albany, NY 12205 

If you have any questions about the content of this letter please contact: Dr. Raymond W. BruHo 

at (949) 608-2918. 

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations 

at your facility. It is your responsibility to ensure compliance with applicable laws and 

regulations administered by FDA. The specific violations noted in this letter and in the Fonn 

FDA 483, Inspectional Observations (FDA 483), issued at the close out of the inspection may be 

symptomatic of serious problems in your firm's manufacturing and quality management 

systems. You should investigate and determine the causes of the violations, and take prompt 

actions to correct the violations and to bring your products into compliance. 

B PV-17 -01-00204242 

Case 2:15-md-02641-DGC Document 9864-1 Filed 01/26/18 Page 13 of 14
'" c.R. Bard Inc. 

Page 13 

bec: 

NYK-DO CB: (Beer/Alexander) 

NYK-DO IE: (Frankovic/Terzian/Wamer/Izyk) 

CFSAN via eMS 

HFI-35 (Purged) via CMS 

Legal file 

CMS Case # 453127 

Elfile C.R. Bard, Queensbury NY (1313046) 

LOS-DO DCB file 

LOS-DO IB [M. Maxwell~ S. Perkins~ M. Saale - e-copies] 

CMS Case # 453127 [issued version for CO redaction] 

Legal File 

Factory File 

Chron [B ruIl 0 ] 

B PV-17 -01-00204243 

Case 2:15-md-02641-DGC Document 9864-1 Filed 01/26/18 Page 14 of 14