Headquarters, Department of the Army, Washington, DC 20310-2300 20 March 2006

Army Medical Department Supply Information

DISTRIBUTION STATEMENT A: Approval for public release; distribution is unlimited

DEPARTMENT OF THE ARMY SUPPLY BULLETIN

 SB 8-75-S3

Table of Contents Page

Section 1 - Medical Materiel Instructions ...................................................................... 1-1

Appendix A - SF 380 (Reporting and Processing Medical Materiel Complaints/

 Quality Improvement Report) - Sample of On-line Form ............................. A-1

Glossary - ............................................................................................................ GL-1

Index - ........................................................................................................... IN-1

Effective until rescinded or superseded

Printing of this information does not constitute endorsement of the product, manufacturer, or the use of

any related item thereof by the U. S. Army.

 REPORTING ERRORS AND RECOMMENDING IMPROVEMENTS

You can improve this publication. If you find any mistakes, or you know a way to improve it, please let

us know. Mail your letter or DA Form 2028 (Recommended Changes to Publications and Blank Forms)

directly to the U. S. Army Medical Materiel Agency, ATTN: MCMR-MMO-S, Fort Detrick, MD 21702-5001. If

you prefer using email, please address it to usammacrm@amedd.army.mil.

SPECIAL NOTICE

THIS SUPPLY BULLETIN IS DEDICATED ENTIRELY TO

MEDICAL MATERIEL INSTRUCTIONS FROM THE

US ARMY MEDICAL MATERIEL AGENCY FOR THE DEPARTMENT OF DEFENSE
SB 8-75-S3 

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SECTION 1. MEDICAL MATERIEL INSTRUCTIONS 

1-1. SUBMITTING MEDICAL/DENTAL PRODUCT QUALITY DEFICIENCY 

REPORTS (M/DPQDR) – [FORMERLY MEDICAL MATERIEL COMPLAINTS 

(SF 380’S)]

 

a. All medical materiel complaints, regardless of procurement source, should 

be submitted on a Medical or Dental Product Quality Deficiency Report (M/DPQDR). 

A M/DPQDR should be submitted to report materiel or equipment that has been 

determined to be harmful and/or defective that may result in death, injury, or 

illness. M/DPQDRs are categorized into two types: 

• Category I: Materiel that has been determined by use or testing to be 

harmful or defective to the extent that its use has or may cause death, injury, or 

serious illness. 

• Category II: Drugs, devices, supplies, or equipment that is suspected of 

being harmful, defective, deteriorated, or unsatisfactory because of malfunction or 

design, which are attributable to faulty materiel, workmanship and/or quality 

inspection, or performance or are otherwise unsuitable for use. 

b. An M/DPQDR is the customer's way of alerting the system that there is a 

quality deficiency with a medical or dental product. Deficiencies should be submitted 

on standard and nonstandard items. It is also the vehicle for submitting Safe Medical 

Device (SMD) incidents. Examples of discrepancies which should be reported on the 

M/DPQDR are: 

• Wrong or deficient labeling 

• Foreign or particulate matter in liquids and solids 

• Imperfectly manufactured items which are off-color, off-taste, and 

off-odor 

• Suspected sub-potency or super-potency 

• Defective devices 

• Pinholes in tubing 

• Faulty calibrations 

• Systemic equipment failures 

• Poor quality products 

c. The submitter will receive a copy of the e-mail that has been sent to 

DSCP, the Defense Medical Standardization Board (DMSB) and the Services’ Medical 

Logistic Offices at Ft Detrick. Once the form is received, DSCP will assign a Report 

Control Number (RCN) in the Product Data Reporting and Evaluation Program 

(PDREP), and respond back to you normally within two days. For more information 

about the PDREP program go to the following website: 

http://www.nslcptsmh.navsea.navy.mil/pdrep/pdrep.htm 

d. Report the circumstances of Category I (Type I complaints) immediately to 

DSCP, through the M/DPQDR, or by telephone. 

 

(1) During normal duty hours (0700 - 1700 hours Eastern Time), call the 

DSCP Emergency Supply Operations Center (ESOC) at DSN 444-2111/2112, or 

commercial 215 737-2112. A telefax may also be sent to: Commercial 

215 737-2081/7109 or DSN 444-2081/7109. 
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(2) After duty hours, the numbers called above will automatically transfer 

to the Staff Duty Officer. If the transfer does not occur or the call is not answered, 

call the following numbers: DSN 444-2341 or commercial 215 737-2341. 

 

e. The 21 CFR prescribes reporting certain materiel/equipment conditions to 

the FDA under the Safe Medical Devices Act (SMDA). Logistics personnel will 

coordinate and provide a copy of the Complaint Form to the Risk Manager as part of 

the Risk Management Program. The Risk Manager is required under Joint 

Commission on Accreditation of Healthcare Organization (JCAHO) to review the 

SMDA information on the Complaint Form and assess the potential risk. 

***A sample of the M/DPQDR is shown at Appendix A.*** 

1-2. DEPARTMENT OF DEFENSE MEDICAL MATERIEL QUALITY CONTROL 

(DOD-MMQC) MESSAGES AND DEPARTMENT OF THE ARMY MEDICAL 

MATERIEL INFORMATION (MMI) MESSAGES 

a. The DoD-MMQC messages is a Tri-Service centralized reporting system 

developed to maintain a readiness posture by providing our MTOE activities, ships, 

and other deployed field units the same quality assurance (QA) information afforded 

fixed/TDA facilities. The DoD-MMQC process is an Integrated Medical Logistics Group 

initiative, designed to simultaneously disseminate QC information and rapidly notify 

hospitals, clinics, and medical units aboard ships or on foreign soil of potentially 

hazardous medical materiel. These messages contain urgent QA data emanating 

from pharmaceutical and/or medical device and equipment manufacturers regarding 

their products. 

b. Once received at the Defense Supply Center Philadelphia (DSCP), research 

is conducted by DSCP and USAMMA’s Distribution Operations Center (DOC) 

(MCMR-MMO-SO) to equate the product with National Stock Numbers (NSNs). 

USAMMA’s DOC then incorporates information into the DoD-MMQC message format 

that contains all Service-specific requirements, Point of Contact (POC), reason for 

message, disposition instructions, and any other product related information. The 

program’s primary purpose is to aid the Service-specific logisticians, supply 

managers, pharmacists, clinicians, medical maintenance personnel, in assuring that 

the proper use, handling, and return of recalled product is accomplished to protect 

patient safety. 

c. The recalls are classified as follows: 

(1) Class I: A situation in which there is a reasonable probability that 

use of, or exposure to, a dangerous product will cause serious adverse health 

consequences or death. 

 

(2) Class II: A situation in which the use of, or exposure to, a 

dangerous product may cause adverse health consequences. 

(3) Class III: A situation in which the use of, or exposure to, a 

dangerous product is not likely to cause adverse health consequences. 
SB 8-75-S3 

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d. The DOC also disseminates Army Medical Materiel Information (MMI) 

messages that contain information specific to the Army only. 

e. These messages are available via two media: 

(1) The World Wide Web (WWW) (available on the USAMMA Homepage 

at http://www.usamma.army.mil. Select “DoD-MMQC Messages” and follow 

appropriate prompts. 

(2) Electronic Mail. Register to receive DoD-MMQC and MMI messages 

via e-mail by subscribing on USAMMA’s website (address above). Select “DoDMMQC Messages” the “Subscribe to MMQC Messages Here” and provide all required 

information. 

f. These messages are also disseminated via: 

(1) File-transfer protocol (FTP) to USAMMCE (Germany) and 16th MLB 

(Korea) 

(2) Joint Medical Asset Repository (JMAR) 

(3) Defense Medical Logistics Supply System (DMLSS) 

1-3. SAFE MEDICAL DEVICE ACT (SMDA) OF 1990 

 a. References: 

(1) AR 40-61, Chapter 4, Section V, Para 4-13 and 4-14 

(2) FDA Medical Device Report (MDR) Regulation 

(Website: www.fda.gov) 

(3) Medical/Dental Product Quality Deficiency Report (M/DPQDR) 

 b. Effective 28 November 1991, all Medical Treatment Facilities (MTFs) are 

required to report device-related deaths, serious injuries and reportable 

malfunctions. 

 c. The M/DPQDR and the MedWatch 3500A Mandatory Reporting Form, will 

continue to be used in submitting the incidents, and is not limited to devices, and 

includes equipment as well as pharmaceuticals. All Activities should continue to 

submit M/DPQDRs, IAW AR 40-61, dated 28 Jan 2006, Chapter 4, Section V, 

Para 4-13 and 4-14. 

 d. M/DPQDR reports are not defined as Type I, Type II or Type II complaints 

[as previously identified with Medical Materiel Complaints (SF 380’s)]. Categories 

of the M/DPQDR are categorized as a category 1 or 2. A category 1 complaint is 

described as an item or event that could cause serious injury or illness or loss of 

life. Category 1 can only be submitted with the approval of a medical officer. All 

others are category 2. 

 e. User-facilities such as hospitals and nursing homes are legally required to 

report suspected medical device-related deaths to both the Food and Drug 

Administration (FDA) and the manufacturer, if known, and serious injuries to the 

manufacturer or to FDA, if the manufacturer is unknown. These reports must be 

made on the MedWatch 3500A Mandatory Reporting Form. 
SB 8-75-S3 

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 f. The statutory authority for the MDR regulation is section 519(a) of the 

Federal Food Drug & Cosmetic (FFD&C) Act as amended by the SMDA of 1990. 

The SMDA requires user facilities to report: 

(1) device-related deaths to the FDA and the device manufacturer; 

(2) device-related serious injuries to the manufacturer, or to FDA if the 

manufacturer is not known; and 

(3) submit to FDA on an annual basis a summary of all reports 

submitted during that period 

 g. The SMDA requires FDA to issue regulations requiring distributors to report 

device-related deaths, serious injuries and reportable malfunctions. In addition, the 

SMDA requires distributors and manufacturers to certify to FDA the number of MDR 

reports filed or that no reports have been filed. All manufacturers of finished medical 

devices and components which are ready for use, including foreign manufacturer’s 

are now subject to the requirements of the MDR regulation, despite registration 

status. 

1-4. SUBMITTING SUPPLY DISCREPANCY REPORTS (WebSDR) – 

[FORMERLY REPORTS OF DISCREPANCY (SF 364)] 

a. All Supply Discrepancy Reports should be done electronically under the 

Department of Defense’s Supply Discrepancy Reporting (SDR) system created by the 

Defense Logistics Agency (DLA). The Defense Automatic Addressing Service Center 

(DAASC) is responsible for the development and support of this project. 

b. The goal of WebSDR is to move SDRs into an integrated transactional 

environment thereby providing an effective means to report and measure 

discrepancy related data and pipeline performance and to help achieve near real time 

SDR reporting, enable Perfect Order Fulfillment computations, facilitate 

interoperability internal and external to DoD, and maximize the economy, efficiency, 

effectiveness of the reporting process. 

c. To submit a SDR on-line, go to: https://www.daas.dla.mil/websdr

d. You must register, providing all information required; once complete, 

submit and you will be provided a password. Once received, then comply with 

instructions outlined. For more information on this web site and the WebSDR 

Application, choose “Contact Us” (top right hand corner) on web page. 

1-5. POINT OF CONTACT 

Questions regarding the information contained within this SB may be directed to: 

USAMMA 

ATTN: MCMR-MMO-SO 

1423 Sultan DR 

Fort Detrick MD 21702-5001 

DSN 343-4300/3242 or Commercial301-619-4300/3242 
SB 8-75-S3 

A-1 

APPENDIX A. SAMPLE M/DPQDR 

3 4H 5H 6H 7H

Medical/Dental Product Quality Deficiency Report 

Complete the following data fields that are applicable to your Medical/Dental Product Quality Deficiency Report (M/DPQDR). 

The M/DPQDR replaces the Standard Form 380 (SF380). 

The submitter must provide an accurate email address and will automatically receive a copy of data submitted. 

When finished, click on the Submit button at the bottom. 

For further instructions about how this form should be completed, please click here. 

Date deficiency found or event occurred 8H Assigned Document Number 

Complaint Information 

Category: I Product or event that could cause serious injury or death 

 II All others 

Cause of Complaint - Explanation of unsatisfactory condition, deficiency, or description of reaction 

Approximate amount of time in use before failure(days) 

Total patients involved Total reactions Patients without reaction 

Note: Complete the following items for DoD category I complaints only 

Reactions requiring hospitalization Length of hospital stay (days) Severe or unusual reactions 

Product Information 

NSN (if known) Part or model number* Serial number 

*For pharmaceuticals, indicate either the NDC or UPC numbers

Item description 

Lot numbers (defective) Batch number Defective item is Item under warranty
SB 8-75-S3 

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Quantity on-hand Quantity recieved Quantity inspected Quantity deficient Quantity suspended 

Manufacturer name Manufacturer phone CAGE code (if known) Manufacturer address 

Vendor/Distributor name Vendor/Distributor phone CAGE code Vendor/Distributor address 

What is the current location of the defective materiel (provide DoDAAC if known) 

Procurement Information 

Contract Number DoD Requisition Number* Purchase Order Number 

* 14 digit code for refund on DFAS items

Source of procurement If other, please specify Gov. furnished? 

Date packed 

9H

Expiration date 

10H

Date recvd/repaired

1H

Unit cost Estimated repair cost

Actions 

Has the manufacturer or distributor been notified? Yes No N/A 

If so, which company was notified? What actions were taken? 

Do you seek credit or replacement? Credit Replacement N/A 

MedWatch Report 

Was the MedWatch Report submitted to the FDA? (see instructions) Yes No N/A 

If yes, was it? Mandatory 3500A Form 12Hhttp://www.fda.gov/medwatch/safety/3500a.pdf

Voluntary 3500 Form 13Hhttps://www.accessdata.fda.gov/scripts/medwatch

No form submitted 

If no, do you want DSCP to submit a Voluntary MedWatch Report for you? We will provide you a copy of what is reported. Yes No N/A 
SB 8-75-S3 

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From 

Activity name DoDAAC Activity address 

Submitter's name DSN phone Comm. phone Fax Email 

Supply Officer's name DSN phone Comm. phone Fax Email 

PoC for additional info DSN phone Comm. phone Fax Email 

Authorizing Medical Officer 

for Category I complaints DSN phone Comm. phone Fax Email 

Any other comments or questions relating to this complaint 

Submit Query Start over

A-3 (A-4 blank) 
SB 8-75-S3 

GL-1 

GLOSSARY 
SB 8-75-S3 

GL-1 (GL-2 blank) 

2006 GLOSSARY FOR SB 8-75-S3 

Abbreviation/Acronym Definition

AMEDD --------------------------------------------------------------------Army Medical Department 

CFR --------------------------------------------------------------------- Code of Federal Regulations 

DA -------------------------------------------------------------------------- Department of the Army 

DAASC---------------------------------------------- Defense Automatic Addressing Service Center 

DOC ------------------------------------------------------------------Distribution Operations Center 

DLA ----------------------------------------------------------------------- Defense Logistics Agency 

DMLSS---------------------------------------------------- Defense Medical Logistics Supply System 

DOD --------------------------------------------------------------------------Department of Defense 

DOD-MMQC ----------------------------- Department Of Defense Medical Materiel Quality Control 

DMSB ------------------------------------------------------- Defense Medical Standardization Board 

DSCP ----------------------------------------------------------- Defense Supply Center Philadelphia 

DSN-----------------------------------------------------------------------Defense Switched Network 

ESOC --------------------------------------------------------- Emergency Supply Operations Center 

FDA ------------------------------------------------------------------- Food and Drug Administration 

FFD&C ----------------------------------------------------------------Federal Food Drug & Cosmetic 

FTP ----------------------------------------------------------------------------- File Transfer Protocol 

JCAHO ----------------------------- Joint Commission on Accreditation of Healthcare Organization 

JMAR ---------------------------------------------------------------- Joint Medical Asset Repository 

MMI ---------------------------------------------------------------------Medical Materiel Information 

MMQC -------------------------------------------------------------- Medical Materiel Quality Control 

M/DPQDR------------------------------------- Medical or Dental Product Quality Deficiency Report 

NSN ------------------------------------------------------------------------ National Stock Number 

PDREP -------------------------------------------- Product Data Reporting and Evaluation Program 

POC -----------------------------------------------------------------------------------Point of Contact 

PQDR ------------------------------------------------------------ Product Quality Deficiency Report 

QDR ----------------------------------------------------------------------- Quality Deficiency Report 

RCN---------------------------------------------------------------------------Report Control Number 

SF-------------------------------------------------------------------------------------- Standard Form 

SDR------------------------------------------------------------------- Supply Discrepancy Reporting 

SMD ----------------------------------------------------------------------------- Safe Medical Device 

SMDA ----------------------------------------------------------------------- Safe Medical Devices Act 

USAMMA---------------------------------------------- United States Army Medical Materiel Agency 

USAMMCE ------------------------------------United States Army Medical Materiel Center, Europe 

USAMRMC ------------------------- United States Army Medical Research and Materiel Command 
SB 8-75-S3 

IN-1 (IN-2 blank) 

2006 INDEX - SB 8-75-S3 

SUBJECT SB 8-75- PAGE

 

Department Of Defense Medical Materiel Quality Control 

(DOD-MMQC) Messages And Department Of The Army Medical 

Materiel Information (MMI) Messages 

S3 1-2 

 

Glossary For SB 8-75-S3 S3 GL-1 

 

Point Of Contact S3 1-5 

 

Safe Medical Device Act (SMDA) Of 1990 S3 1-3 

Sample M/DPQDR S3 A-1 

Submitting Medical/Dental Product Quality Deficiency Reports (M/DPQDR) 

– [Formerly Medical Materiel Complaints (SF 380’s)] S3 1-1 

Submitting Supply Discrepancy Reports (WebSDR) – [Formerly 

Reports Of Discrepancy (SF 364)] S3 1-4 

 
SB 8-75-S3 

By Order of the Secretary of the Army: 

PETER J. SCHOOMAKER 

General, United States Army 

Chief of Staff 

Official: 

JOYCE E. MORROW 

Administrative Assistant to the 

Secretary of the Army 

Distribution: 

 To be distributed in accordance with initial distribution number (IDN) 340016, requirements for the 

SB 8-75 Series. 
PIN: 063917-000