Sex: U
Vaccine: PNC13
Symptoms: Syringe issue
Clinical narrative: when they opened up the Prevnar 13 packaging they noticed the tip of one of the prefilled syringes was busted; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from product quality group. Other Case identifier: VZ2OQGWK.   A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Lot number: EJ4560, Expiration Date: 31Jul2023, Device Lot Number: EJ4560, Expiration Date: 31Jul2023) as dose number unknown, single and (Lot number: EJ4559) as dose number unknown, single for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "when they opened up the Prevnar 13 packaging they noticed the tip of one of the prefilled syringes was busted". The sample of the product is available to be returned, if requested. On 07Dec2021 and 23Dec2021, investigation results were received. Description of Complaint: Description of complaint: Partner company who received a damaged Prevnar 13 vial and he is calling on their behalf. Caller states only one vial was damaged and they sent him pictures. Caller states there were no patients involved and they reported it to him right after receiving it. Reasonably Suggest Device Malfunction was No. Severity of Harm: N/A. Summary of Investigation: The (Site Name 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. However, without complaint sample and based on the available information it is not possible to perform a more profound investigation and/or root cause analysis. 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. Addition by name withheld on 22Dec2021.No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. (Site Name 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. Special or Common Cause: Common Cause Root Cause is always present to some degree in the process. Special Cause Root Cause is something different happening at a certain time or place in the process. Conclusion: The complaint for "Busted syringe tip" of Prevnar 13V Injectable was investigated. The investigation included reviewing the involved batch records, deviation investigation, evaluation of retain sample, an analysis of the complaint history for the reported lot and product type and Annual Product Review. The final scope was determined to be the associated lot of the reported lot EJ4560. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. (Site Name 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 not be confirmed on evaluation of retain samples. No root cause were identified as the complaint was not confirmed. Rsrv. Sample Evaluation Reqd: Yes. Visual Resrv Sample Eval Desc: Quantity of reference samples reviewed: 1 package of Prevenar containing 2 blisters and 1 insert. The blisters contain each 5 Syringes. Examination results: 1 package of Prevenar containing 2 blisters, 1 insert and 10 syringes have been visually inspected. No damaged syringes or other defects could be observed. A functionality test has been performed on one of the syringes. No defects could be observed. QA check OK: During this retain sample evaluation, the 'minimum required remaining retain samples' was checked and respected. Reserve Sample Testing Req'd: No. Confirmed Reserve Defect: No. Lot-Specific Trend Identified: No. Site Sample Status: Not Received. On 04Jan2022, investigation results for the complaint "Busted syringe tip" of PREVNAR 13V INJECTABLE was received. Complaint Class : Container. Complaint Sub Class: Container Broken/Cracked /Leaking Prior To Use. This complaint is device related and assigned to it a severity rate of S3. Summary of Investigation: Following completion of the investigation it is determined that a regulatory notification is required for this complaint, refer to # raised by (site name). The findings of the (site name) 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. A sample/photo were not returned for the complaint. Trend/Complaint History: A lot specific trend was not identified For the Fill Lot. A trend was not identified for complaints reporting a broken tip following a review of the syringe barrel lots used to manufacture the Fill Lot. Review of reports: A review of the three latest APQR (Annual Product Quality Review) reports was performed - RPT-78544 (2018), RPT-94334 (2019) and RPT-116065. No trends were identified. 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 at (site name) contributed to the reported complaint. Root cause: Process Related: No. Final Confirmation Status: Not Confirmed. Vendor Related: No. Root Cause Analysis/Identif: No evidence was found to indicate that manufacturing activities at (site name) contributed to the reported complaint. In the absence of a returned complaint sample, a definitive root cause was not identified for the reported complaint. Impact Analysis: Following review of the investigation results based on the final scope, there is no evidence that manufacturing activities at (site name) contributed to the reported complaint. A lot specific trend was not identified. The reported complaint is not representative of the quality of the batch and the batch remains acceptable. Root Cause Category (Tier 1): Non-assignable (Complaint Not Confirmed); Root Cause Category (Tier 2): Non-assignable (Complaint Not Confirmed); Root Cause Category (Tier 3): N/A. Special or Common Cause: Common Cause Root Cause is always present to some degree in the process. Special Cause Root Cause is something different happening at a certain time or place in the process. Improve/Control: Corrective / Preventive Action: Following investigation, no evidence was found to indicate that manufacturing activities at withheld contributed to the reported complaint, therefore no corrective and preventative actions were identified.  Complaints for this defect 'broken tip' are monitored by withheld, any required corrective actions will be documented. Conclusion: This complaint reported broken syringe tip for a Prevnar/Prevenar 13V syringe. The (site name) Fill Lot is DX7780. Following investigation, the final scope was limited to the (site name) Fill Lot as a trend was not identified and no evidence was found to indicate that manufacturing activities at (site name) contributed to the reported complaint. The investigation included a review of; batch and process records, a lot history review and a reserve review for the lot(s) in scope. A sample/photo were not returned for this complaint. An evaluation of the complaint history confirms that there is one complaint 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. There are controls in place at (site name) 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 at (site name) and no corrective/preventative actions are required. After assessment of the complaint, it was determined that a regulatory notification is Required, refer to #. Complaints for this defect 'broken tip' are monitored by (site name), any required corrective actions will be documented. Batch and process record review: Scope of Compl. Investigation: The initial scope is limited to the Fill Lot, refer to the related lots grid. A review of the batch records for the lots in scope was performed. Process record Review: A review of manufacturing investigations related to the lot(s) in scope was performed on 06Dec2021 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. Following a review of the results above, no evidence was found that manufacturing activities at (site name) contributed to the reported complaint.  A search for prior deviations was performed on 06 Dec 21 according to the following search criteria. 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. Reserve sample evolution: Rsrv. Sample Evaluation Reqd: Yes. Visual Resrv Sample Eval Desc: All reserve samples were inspected for 'Physical Inspection' as per #. Reserve Retention Sample Reviews for Customer Complaint Investigations. No defects were observed related to the reported complaint. Confirmed Reserve Defect: No. Lot-Specific Trend Identified: No. Lot Trend Assmt. & Rationale: (site name) Fill Lot DX7780 was packed into packaged lots; EJ4560 only. A review for priors was performed on 06Dec2021 according to the following search criteria; Scope: Complaint Records Lot# is any of: EJ4560 Complaint Class is any of: All records including closed The following additional complaint was returned; #, subclass "Container Leaking During Prep/Use" reported ''solution came out of the pre-filled syringe at the base of the syringe and where the safety needle is screwed in '' An evaluation of the complaint history confirmed a total of two complaints for the Filled Lot for complaint Class 'Container' of which one complaint (Current complaint) was reported for complaints subclass 'Container Broken/Cracked/Leaking Prior To Use'. A lot specific trend was not identified; therefore, the scope of this investigation is limited to the (site name) Fill lot. Lot Trend Actions Taken: No actions required. Other Trend Identified: No. Other Trend Assessment & Rationale: A review of the syringe barrel lots used in the manufacture of Fill Lot DX7780 was performed on 30 Dec 21. Material lot #: PAA058167 Barrel lot #: 2001329859, 2001330249, 2001326378, 2001330216 Additional Fill lots: EA9588, EA9677, EA9693, EA9678, EA9692, EA4760, DX7806 Additional Package lots: EK6267, EG8728, EJ9050, EJ5220, EL8002, EK8920, EF1697, EJ7432, EJ8572, EM9861, EM9860, EM9876, EL7033, EM9853, EK1788, EN8034, EN8815, EK0827, EJ4562, EG0787, EE7115 A search for prior complaints for the additional packed lots was performed on 30 Dec 21 as per the following search criteria. Scope: Complaint Records Query: All Records (Including Closed) Lot# is any of: EK6267, EG8728, EJ9050, EJ5220, EL8002, EK8920, EF1697, EJ7432, EJ8572, EM9861, EM9860, EM9876, EL7033, EM9853, EK1788, EN8034, EN8815, EK0827, EJ4562, EG0787, EE7115 Complaint Class: All records including closed No additional complaints were identified for Class 'Container'. A trend was not identified for the syringe barrel lots used in the manufacture of (site name) fill lot DX7780, for complaint Class 'Container'. The scope of this investigation is limited to the Fill Lot. Complaint Status: (Parent) Sample Status: Sample Availability Unknown. Site Sample Status: Not Received. Confirmed Compl Sample Defect: N/A - Not Received. On 13Jan2022, additional information was received. However, the received sample has lot EJ4559. Caller on the line calling back in follow up to a report on Prevnar 13. Caller verified the information provided by the transferring agent and states he previously provided the lot number for the Prevnar 13 to Pfizer but provided it again today and states what occurred was that when they opened up the Prevnar 13 packaging they noticed the tip of one of the prefilled syringes was busted and pictures were sent to Pfizer. Caller states he wanted to just see where to go from here and should he wait another 3 business days to see if the return package shows up for him or for the partner. Description of complaint: partner company who received a damaged Prevnar 13 vial and he is calling on their behalf. Caller states only one vial was damaged and they sent him pictures. Caller states there were no patients involved and they reported it to him right after receiving it. Looking for Credit. Additional lot numbers: None. Is a sample of the product available to be returned, if requested: Yes. Sample Status: Received. Packaging sealed and intact: Yes.   No follow-up attempts are possible. No further information is expected.