Sex: U
Vaccine: PNC13
Symptoms: Syringe issue
Clinical narrative: prefilled syringes that broke when they were going to administer it to patients; no patients received/actual lure lock that the needle screws into broke off on both; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Lot number: DF1306, Expiration Date: 31Aug2022) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), described as "prefilled syringes that broke when they were going to administer it to patients; no patients received/actual lure lock that the needle screws into broke off on both".It was explained that the actual lure lock that the needle screws into broke off on both. She discarded the needle in the sharps container but kept the vials for return. The packs were sealed and intact and there were no problem with any other syringes in the same containers.   Investigation result received on 29Jun2021 for the complaint " she remarks it is tiny and she is old, that is why it took so long to read. It was explained that the actual lure lock that the needle screws into broke off on both. She discarded the needle in the sharps container but kept the vials for return. The packs were sealed and intact and there were no problem with any other syringes in the same containers" involving Prevnar 13 (Lot: DF1306, Expiry: Aug2022) showed that there was a reasonably suggest device malfunction and severity of harm was S1.Impact Analysis:No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. (Withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. A BPDR will be issued.Corrective / Preventive Action:No corrective or preventive actions were identified as all reviewed records for the involved batch indicated that the batch met the established requirements at time of release.Conclusion:The complaint for Container Broken/Cracked During Prep/Use of PREVENAR 13V INJECTABLE was investigated. The investigation included reviewing the involved batch records, deviation investigation, complaint sample, evaluation of retain samples, an analysis of the complaint history for the reported lot and product type and Annual Product (Quality) Review. The final scope was determined to be the associated lot(s) of the reported lot DF1306. The reported defect was present on the returned complaint sample.No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. (Withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required The reported defect could be confirmed on the returned complaint sample. No root cause or CAPA were identified as all reviewed records for the involved batch indicated that the batch met the established requirements at time of release. Broken tip complaints are monitored by Pfizer (Withheld).Lot-Specific Trend.Lot-Specific Trend Identified?: No.Lot Trend Attachment: (Withheld)-Complaint History Lot Trend Assmt. & Rationale: Lot history period: date from 28Jun2018 - date to: 8Jun2021 Lot history parameters: SF-batch: CM3130 and subclass: Container Broken/Cracked During Prep/Use The complaint history has been reviewed for the reported batch. As no similar complaints have been received in the past three years, no lot trend signal could be noticed.Lot Trend Actions Taken: No actions required.Other Trending.Other Trend Identified?: No.Other Trend Attachment: Subclass trend - Jun 2021 - B.1 - disposible syringe + luerlock - Container broken cracked during use -No complaint trend could be identified. No actions are required.Site Sample Status: Received at the Site.Date Samples were Received (GMT): 27May2021.Visual Compl Smpl Eval Cmpletd (GMT): 28May2021.Return Sample Evaluation: One syringe was received, without carton or blister. No defects were found on the label. The syringe was empty. The rubber tip cap and needle were missing. The plunger was in end position and the plunger rod was firmly attached. The tip was broken off and it was stuck in the luer lock. The luer lock, with the broken top, was loose.  Investigation result received on 02Jul2021 for the complaint " when reading the NDC she remarks it is tiny and she is old, that is why it took so long to read. It was explained that the actual lure lock that the needle screws into broke off on both. She discarded the needle in the sharps container but kept the vials for return. The packs were sealed and intact and there were no problem with any other syringes in the same container" involving Prevnar 13, NDC: 0005197101 (Lot: DF1306, Expiry: Aug2022) showed that there was a reasonably suggest device malfunction and severity of harm was S1.Summary of Investigation:The initial scope of the investigation is limited to the lots documented in the related lots grid.An NTM was raised by Pfizer (Withheld); Refer to PR (Withheld) after assessment of the complaint it was determined that a BPDR is required. The findings of the investigation are as follows; Batch /Process Record Review: No Findings in relation to the reported complaint. Reserve Sample Evaluation: No defects were observed related to the reported complaint. Complaint Sample Evaluation: The sample was evaluated and confirmed the reported complaint, refer to PR (Withheld) for sample evaluation.Trend/Complaint History: A lot specific trend was not identified For the Fill Lot and associated syringe barrel lots. The final scope was limited to the GC Fill Lot (refer to related lots grid) as no evidence was found to indicate that manufacturing activities contributed to the reported complaint .Root Cause Analysis/Identif:No evidence was found to indicate that manufacturing activities contributed to the reported complaint. The returned sample confirmed the reported complaint. Note: The most likely root cause is attributed to the failure of the glass due to residual thermal stress resulting from the syringe manufacturing process when the tips were formed, and stress was introduced as the glass cooled. Such stress is inherent to the forming process, and while subsequent annealing should mitigate this stress, it may remain present at low levels. Following investigation, no evidence was found to indicate that manufacturing activities contributed to the defect reported in this complaint. Conclusion:This complaint reported a broken syringe tip for a Prevnar 13V syringe. The Fill Lot is CM3130. Following investigation the final scope was limited to the Fill Lot as a trend was not identified and no evidence was found to indicate that manufacturing activities contributed to the reported complaint. The investigation included a review of; batch and process records, a lot history review, Sample Evaluation and a reserve review for the lot(s) in scope. An evaluation of the complaint history confirms that this is the first complaint(s) reported for the Fill Lot for this complaint subclass. A lot specific trend was not identified and a trend was not identified for the associated syringe barrel lots. A sample was returned to Pfizer (Withheld). Refer to (Withheld) investigation PR (Withheld) for sample evaluation. The sample evaluation confirmed the reported defect. The most likely root cause for a broken syringe tip is due to the failure of glass due to residual thermal stress resulting from the syringe manufacturing process when the tips were formed and stress was introduced as the glass cooled. Such stress is inherent to the forming process, and while subsequent annealing should mitigate this stress, it may remain present at low levels. There are controls in place at Pfizer to prevent/detect this defect; the inspection machine detects a missing tip cap, cracks in the barrel and underfill / empty syringes. There were no issues identified during the investigation impacting product quality. A process related root cause was not identified  and no corrective/preventative actions are required. After assessment of the complaint it was determined that a regulatory notification Is Required, refer to (Withheld) NTM 6088077. Complaints for this defect 'broken tip' are monitored, any required corrective actions will be documented. Refer to commitment tracking occurrence PR# (Withheld)Batch/Process Record Review.Scope of Compl. Investigation :The initial scope of this investigation is limited to the Fill Lot, refer to the related lots grid. A review of the batch records for the lot in scope was performed. Refer to review questions below. Process record Review:A review of manufacturing investigations related to the lot(s) in scope was performed in CITI on 28Jun21 according to the following search criteria; Scope: Quality Assurance Report (QAR), Event (ER), Laboratory Investigation Reports (LIR), Commitment Tracking (CT), Change Management (CM) and Notification to Management (NTM) Site: PR text with any of these words: CM3130 More Actions and Text Query Settings; Flexfields, Strings, Selections, Persons, Entities Quick Criteria: Include closed records.Results: No records were returned. No evidence was found that manufacturing activities  contributed to the reported complaint. No change to the initial scope was required following review of the batch and process records.Document Review Summary:A review of batch and process records for the lot(s) in scope, found no deviations which may have contributed to the reported complaint. Controls are in place to prevent/detect the reported complaint. The inspection machine has 100% detection for underfilled/empty syringes and also detects a missing tip cap and cracked barrel.Reserve Sample Evaluation.Rsrv. Sample Evaluation Reqd?: Yes.Rsrv Sample Eval Cmpletd (GMT): 28Jun2021.Visual Resrv Sample Eval Desc.: All reserve samples were inspected for Physical Inspection as per SOP-(Withheld) Reserve Retention Sample Reviews for Customer Complaint Investigations. No defects were observed related to the reported complaint. Refer to # (Withheld).Reserve Sample Testing Reqd?: No.Confirmed Reserve Defect?: No.Lot-Specific Trend.Lot-Specific Trend Identified?: No.Lot Trend Assmt. & Rationale: Fill Lot CM3130 was packed into packaged lot(s); DF1306, DE8785 A review for priors was performed in QTS (CITI) on 28Jun21 according to the following search criteria; Scope: Complaint Records (pub) Lot# is any of: DF1306, DE8785 Complaint Class is any of: Container Quick Criteria: All records including closed No additional complaints were identified. A lot specific trend was not identified; therefore, the scope of this investigation is limited to the associated fill lot. Pfizer is currently monitoring complaints reporting broken tips.3 additional complaints were identified for subclass Container Broken/Cracked During Prep/Use and 3 additional complaints were identified for subclass Container Broken/Cracked/Leaking Prior to Use. 5 of these complaints reported a broken tip. This defect broken tip is captured in the Design (INX withheld v7.0) under Failure Mode 002 (FM002). The potential failure mode is: Syringe Barrel, Nozzle, or Flange deformed, Broken or cracked. The potential Cause(s), Mechanisms of failure are as follows.1. Requirements - Inadequate specification of design parameters:Material is too brittle - Inadequate material attributes specified to prevent breakage or cracks (e.g., wall thickness or annealing strength) (breaks due to flexural loading, vertical loading, torsional loading, internal pressure, and thermal stress observed during fill/finish, shipping and storage conditions (breaks due to flexural loading, torsional loading, and internal pressure observed during preparation / administration).The P1 value for Failure mode FM002 is documented as moderate in the Design FMEA (1:10,000 - 1:100,000) which equates to 10-100 complaints per million. The syringe barrel lots identified for this complaint were used in a total of 9 Fill Lots (4,338,300 doses). With a total of 6 complaints reported for a broken tip for these Fill Lots this equates to 1.4 complaints per million. A trend was not identified.Return Sample Evaluation: Samples were returned to Pfizer (Withheld). Refer to (Withheld) investigation PR (Withheld) for sample evaluation.Sample Condition: Other: See Sample Evaluation.Is Compl Sample Testing Recom?: No.Confirmed Compl Sample Defect?: Yes.  Investigation result received on 13May2021 for the complaint " It was explained that the actual lure lock that the needle screws into broke off on both. She discarded the needle in the sharps container but kept the vials for return. " involving Prevnar 13, NDC: 0005197101 (Lot: DF1306, Expiry: Aug2022) showed that there was a reasonably suggest device malfunction and severity of harm was S1.  Investigation result received on 16Mar2022 for the complaint " 2 prefilled syringes that broke when taking the cap off the needle lure lock that the needle screws into broke off on both " involving Prevnar 13 (Lot: DF1306, Expiry: Aug2022_) showed that there was a reasonably suggest device malfunction and severity of harm was S3.Root Cause Analysis/Identif:The (Withheld) investigation could not indicate a probable root cause for the complaint to be related to the production process of the involved batch. All reviewed records for the involved batch indicated that the batch met the established requirements at time of release.Impact Analysis:No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. (Withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. A BPDR will be issued.Conclusion:Updated on 09Mar2022 by ABRU: Severity has been corrected to S3 (See PR# (Withheld) for additional information). The complaint for Container Broken/Cracked During Prep/Use of Prevenar 13v Injectable was investigated. The investigation included reviewing the involved batch records, deviation investigation, complaint sample, evaluation of retain samples, an analysis of the complaint history for the reported lot and product type and Annual Product (Quality) Review. The final scope was determined to be the associated lot(s) of the reported lot DF1306. The reported defect was present on the returned complaint sample. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety . (Withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification (BPDR) was required The reported defect could be confirmed on the returned complaint sample. No root cause or CAPA were identified as all reviewed records for the involved batch indicated that the batch met the established requirements at time of release.Conclusion: Updated on 09Mar2022 by ABRU: Severity has been corrected to S3 (See PR# (Withheld) for additional information). The complaint for Container Broken/Cracked During Prep/Use of Prevenar 13v Injectable was investigated. The investigation included reviewing the involved batch records, deviation investigation, complaint sample, evaluation of retain samples, an analysis of the complaint history for the reported lot and product type and Annual Product (Quality) Review. The final scope was determined to be the associated lot(s) of the reported lot DF1306. The reported defect was present on the returned complaint sample. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety . (Withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification (BPDR) was required The reported defect could be confirmed on the returned complaint sample. No root cause or CAPA were identified as all reviewed records for the involved batch indicated that the batch met the established requirements at time of release.Conclusion:Updated on 09Mar2022 by ABRU: Severity has been corrected to S3 (See PR# (Withheld) for additional information). The complaint for Container Broken/Cracked During Prep/Use of Prevenar 13v Injectable was investigated. The investigation included reviewing the involved batch records, deviation investigation, complaint sample, evaluation of retain samples, an analysis of the complaint history for the reported lot and product type and Annual Product (Quality) Review. The final scope was determined to be the associated lot(s) of the reported lot DF1306. The reported defect was present on the returned complaint sample. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety . (Withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification (BPDR) was required The reported defect could be confirmed on the returned complaint sample. No root cause or CAPA were identified as all reviewed records for the involved batch indicated that the batch met the established requirements at time of release.Lot Trend Assmt. & Rationale: Lot history period: date from 28Jun2018 - date to: -8Jun2021 Lot history parameters: SF-batch: CM3130 and subclass: Container Broken/Cracked During Prep/Use The complaint history has been reviewed for the reported batch. As no similar complaints have been received in the past three years, no lot trend signal could be noticed.Return Sample Evaluation: One syringe was received, without carton or blister. No defects were found on the label. The syringe was empty. The rubber tip cap and needle were missing. The plunger was in end position and the plunger rod was firmly attached. The tip was broken off and it was stuck in the luer lock. The luer lock, with the broken top, was loose.Confirmed Compl Sample Defect?: Yes.the investigation results yielded no Product quality issues.  No follow-up attempts are possible. No further information is expected.