Sex: U
Vaccine: PNC13
Symptoms: Syringe issue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team and product quality group. A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Lot number: DR0570, Expiration Date: 28Feb2023, Device Lot Number: DR0570, Expiration Date: 28Feb2023) as dose number unknown, single for immunisation. 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 "Part of the prefilled syringe is broken, can we still use it?/was going to open the second tray and when she had lifted the paper on top, she saw that the little circle white thing that is around it was broke but all of the vaccine is still in there". Additional information: NDC Number: 0005197101. The complaint was for PREVNAR 13 broken prefilled syringe/part of the prefilled syringe is broken. The reporter said that she did not know if that's how it came or if it had gotten smashed. She knew that they have already used 5 syringes and was going to open the second tray and when she had lifted the paper on top, she saw that the little circle white thing that is around it was broke but all of the vaccine is still in there. Of Complaint: Auto-callback, "Part of the prefilled syringe is broken, can we still use it?". Product strength and count size dispensed: 5 mL, 10 in the box but 5 in each tray. As of 11Jun2021, investigation result was received from Product Quality Complaint Group. Description of complaint: Caller reporting PC on a broken PREVNAR 13 prefilled syringe and says that she really doesn't know if that's how it came or if it had gotten smashed. She just knows that they have already used 5 syringes and was going to open the second tray and when she had lifted the paper on top, she saw that the little circle white thing that is around it was broke but all of the vaccine is still in there. Product strength and count size dispensed: 5 mL, 10 in the box but 5 in each tray. Is a sample of the product available to be returned, if requested (Y/N): Yes, they still have the syringe there because there was still medicine inside of it. The back of the seal around the syringe lock is what broke. As of 09Jul2021, investigation result was received from Product Quality Complaint Group. PR STATE (CR): Pending Investigation. PR state: Approved. Reasonably Suggest Device Malfunction: Yes. Severity of Harm: S3. Process Related: No. Final Confirmation Status: Confirmed. Vendor Related: No. Root Cause Analysis/Identif: The PGS Puurs 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. The complaint sample has been forwarded for further investigation from other departments. The conclusions will be documented in child action item PR#6124585. There is no impact on product quality, regulatory, validation, stability and patient safety. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. Conclusion: The complaint for "broken syringe" of "Prevenar 13V Injectable" was investigated. The investigation included reviewing the involved batch records, deviation investigation, complaint sample, evaluation of retain sample(s), 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 "DR0570". 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. PGS Puurs 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 (BPDR). The reported defect could be confirmed on the 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. Document Review Summary: The associated batch records have been reviewed and were found to be conforming. No complaint related comments or planned deviations were recorded. No controls are in place to prevent or detect the reported defect.Based on a review of the associated deviations, all in-process controls were performed as described in the batch records and procedures. The following in-process controls are in place to prevent or detect the reported defect, IPC Quality Packaging, IPC Quality Process. Deviations and batch records have been reviewed and were conforming. All challenge checks and line start up were performed as described in the batch records and procedures. All line clearances and line clean-ups were performed as described in the batch records and procedures. Deviations have been reviewed and could not be related to the nature of this complaint. The involved defect does not concern a mix-up scenario. No similar defects were found during inspection. Seen the nature of the complaint (Pfizer Puurs only performs packaging of this presentation) this part of the investigation has not been performed as the analytical results at release would not be relevant to the investigation. After review of the APR for the shelf life of the applicable product, the conclusion is that the production is under control and in a validated state. Reserve Sample Evaluation Required: Yes. Examination results: The package with 1 pre-filled syringe and needle in a sealed blister was checked visually. No defects could be observed. Confirmed Reserve Defect: No. Lot-Specific Trend Identified: No. 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. Expedite Trend Identified: No. Site Sample Status: Received at the site. Date Samples were Received (GMT): 24Jun2021.  As of 14Jul2021, investigation result was received from Product Quality Complaint Group. PR State (CR): Pending Investigation. PD state: Closed. Failure Mode: Broken syringe flange. Summary of Investigation: The initial scope of the Grange Castle investigation is limited to the lots documented in the related lots grid. Following completion of the investigation it is determined that Regulatory Notification is not required related to manufacturing activities at Pfizer Grange Castle based on the following; 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: Pfizer Puurs received the complaint sample, refer to PR# 6035976. The sample was returned and confirmed the reported complaint. Trend/Complaint History: A lot specific trend was not identified. The final scope was limited to the Fill Lot (refer to related lots grid) as no evidence was found to indicate that manufacturing activities at Grange Castle contributed to the reported complaint.A review of complaints for Subclass 'Container broken cracked leaking prior to use' was performed for the last three years for Prevnar 13V. A trend was not identified. Review of APQR reports: A review of the three latest APQR (Annual Product Quality Review) reports was performed - RPT-78544 (2018), RPT-94334 (2019) and RPT-1160659 (2020). No trends were identified. A BPDR will be submitted by the packaging site Pfizer Puurs for this complaint refer to PR 6086667. There is no history of flange breakages associated with manufacturing activities at Pfizer Grange Castle. Final Confirmation Status: Confirmed. Vendor Related: No. Conclusion: This complaint reported broken syringe flange for a Prevenar 13V syringe. The Grange Castle Fill Lot is DK2061. The investigation included a review of; batch and process records, a lot history review and a reserve review for the lot(s) in scope. Pfizer Puurs received the complaint sample, refer to PR#. The sample was returned and confirmed the reported 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. 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 at Grange Castle contributed to the reported complaint. Controls are in place to prevent/detect the reported complaint. There were no issues identified during the investigation impacting product quality. The complaint was not confirmed and is not process related. A root cause was not identified, and no corrective/preventative actions are required. A regulatory notification is not required by Pfizer Grange Castle. A BPDR will be submitted by the packaging site Pfizer Puurs for this complaint refer to PR #. There is no history of flange breakages associated with manufacturing activities at Pfizer Grange Castle. No further action is required. As of 03Aug2021, investigation result was received from Product Quality Complaint Group. PR STATE(CR): Pending Investigation. PD state: Approved. Severity of Harm: S3.  Full Investigation Required: Yes. Process Related: No. Final Confirmation Status: Confirmed. Vendor Related: No. Conclusion: Update after completion of the complaint sample investigations in action item PR#, HELM, 08Mar2021. The complaint for "broken syringe" of "Prevenar 13V Injectable" was investigated. The investigation included reviewing the involved batch records, deviation investigation, complaint sample, evaluation of retain sample(s), 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 "DR0570". 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. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required (BPDR). The reported defect could be confirmed on the 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. Document Review Summary: The associated batch records have been reviewed and were found to be conforming. No complaint related comments or planned deviations were recorded. No controls are in place to prevent or detect the reported defect. Based on a review of the associated deviations, all in-process controls were performed as described in the batch records and procedures. The following in-process controls are in place to prevent or detect the reported defect, IPC Quality Packaging, IPC Quality Process. Deviations and batch records have been reviewed and were conforming. All challenge checks and line start up were performed as described in the batch records and procedures. All line clearances and line clean-ups were performed as described in the batch records and procedures. Deviations have been reviewed and could not be related to the nature of this complaint. The involved defect does not concern a mix-up scenario.  No similar defects were found during inspection. Seen the nature of the complaint (Pfizer Puurs only performs packaging of this presentation) this part of the investigation has not been performed as the analytical results at release would not be relevant to the investigation. Reserve Sample Evaluation Required: Yes. Examination results: The package with 1 pre-filled syringe and needle in a sealed blister was checked visually. No defects could be observed. Reserve Sample Testing Required: No. Confirmed Reserve Defect: No. Lot-Specific Trend Identified: No. Lot Trend Actions Taken: No actions required. No follow-up attempts are possible. No further information is expected.