Sex: U
Vaccine: PNC13
Symptoms: Syringe issue
Clinical narrative: 1 Prevnar 13 prefilled syringe was damaged/the neck of the Prevnar 13 prefilled syringe (between where the Prevnar 13 dose and the needle gets attached) snapped off; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Lot number: AP2987, Expiration Date: 31Jul2021, Device Lot Number: AP2987, Expiration Date: 31Jul2021) 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), described as "1 Prevnar 13 prefilled syringe was damaged/the neck of the Prevnar 13 prefilled syringe (between where the Prevnar 13 dose and the needle gets attached) snapped off". Additional information: Reported out of a box of 10 Prevnar 13 prefilled syringes, only 1 Prevnar 13 prefilled syringe was damaged. She stated a nurse reported the neck of the Prevnar 13 prefilled syringe (between where the Prevnar 13 dose and the needle gets attached) snapped off when the Prevnar 13 prefilled syringe was taken out of the Prevnar 13 box. The nurse was unable to use the Prevnar 13 prefilled syringe. Reporter inquired about a replacement or credit for the damaged Prevnar 13 prefilled syringe.  Product Quality Group provided investigational results on 16Mar2022, 22Mar2022 and 06Apr2022 for pneumococcal 13-val conj vac (dipht crm197 protein): Conclusion: Updated on 02Mar2022: Severity has been corrected to S3. Additional review of the Annual Product Review is now required. The complaint for a broken syringe from Prevenar 13 lot AP2987 was investigated. The investigation included a review of the labelling and packaging batch records, an evaluation of the return sample, deviation investigations and an analysis of the complaint history for the reported lot, product type and Annual Product Review. This product is received as an unlabelled, sealed pre-filled syringe, and only labelling and secondary packaging is performed by the Pfizer site. Therefore, the final scope was determined to be the reported finished product lot AP2987. The complaint sample evaluation concluded the complaint is confirmed. No related quality issues were identified during the investigation. There is impact on product quality and patient safety as the reported defect renders the delivery system unusable, and hence could result in a missed dose. The root cause has been attributed to Material. No trend has been identified based on a review of the complaint count per lot for the same product, class and sub-class. The investigation included a review of batch records, manufacturing investigations, reserve review, returned sample evaluation and a lot history review for the Fill Lot and associated syringe barrel lots. A trend was not identified for Fill Lot X37606 or the associated syringe barrel lots. Site perform formulation and filling activities for the fill lot. Therefore the final scope of the investigation was limited to Site Fill Lot X37606 and the associated syringe barrels lots, refer to related lots grid. A returned sample confirmed the reported complaint of 'broken tip'. Following investigation, a process related root cause was not identified at (Site Name withheld) for this reported complaint. There are controls in place with regard to Pfizer Site processes to prevent/detect this defect; the inspection machine detects a missing tip cap and cracked barrel. The most likely root cause for this defect 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. For this reason the complaint was considered as vendor related. There is no impact on product quality and patient safety. A trend was not identified. Breakages of this type (broken tip) are catastrophic and render the syringe unusable. Consequently, the actual impact to the patient is limited to a delayed dose (S1). The sample was returned and evaluated. Received at the Site on 04Jan2021. Evaluation: The syringe label was removed. The syringe was observed under hand magnification. The glass barrel and flange were free from damage or defects. The shoulder of the barrel was free from damage or defects. The syringe tip had been broken off cleanly after the syringe shoulder. The breakage zone on the barrel and on the tip were both smooth. The tip was unable to be removed from the luerlok. No other damage, cracks (penetrative or propagating) or abnormalities regarding the shape or appearance of the glass were observed. Consequently, no further testing is required. The reported defect is confirmed. Conclusion: Updated CMcS 06Apr2022. The severity of this complaint was updated to S3. A review of the Annual Product review was required as a result of this update. No trends were identified. A review of complaints for Complaint Subclasses 'Container Broken/Cracked/Leaking Prior to Use' and 'Container Broken/Cracked During Prep/Use' was performed for the last three years for Prevnar/Prevenar 13, Prevnar/Prevenar 20 and similar product Trumenba. A trend was not identified. Following investigation of this complaint which reported a syringe with a broken tip for a Prevnar 13V syringe for Pack Lot AP2987 (Fill Lot: X37606), no evidence was found to indicate that this complaint occurred as a result of manufacturing activities. The investigation included a review of batch records, manufacturing investigations, reserve review, returned sample evaluation and a lot history review for the Fill Lot and associated syringe barrel lots. A trend was not identified for Fill Lot X37606 or the associated syringe barrel lots. Pfizer perform formulation and filling activities for the fill lot. Therefore the final scope of the investigation was limited to Fill Lot X37606 and the associated syringe barrels lots, refer to related lots grid. A returned sample confirmed the reported complaint of 'broken tip'. Following investigation, a process related root cause was not identified for this reported complaint. There are controls in place with regard to Pfizer processes to prevent/detect this defect; the inspection machine detects a missing tip cap and cracked barrel. The most likely root cause for this defect 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. For this reason the complaint was considered as vendor related. There is no impact on product quality and patient safety. A trend was not identified. Breakages of this type (broken tip) are catastrophic and render the syringe unusable. Consequently, the actual impact to the patient is limited to a delayed dose (S1). Complaints for this defect 'broken tip' are monitored and any required corrective actions will be documented in commitment. Root Cause Analysis/Identif: 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 at contributed to the defect reported in this complaint. Complaints for this defect 'broken tip' are monitored, refer to PR# 5057834. Impact Analysis: A trend was not identified for the Fill Lot or the syringe barrel lots for syringes with broken tips, there is no impact to the quality of the batch. Corrective/Preventive Action: No corrective actions have been identified at this time.   No follow-up attempts are possible. No further information is expected.  Follow-up (16Mar2022, 22Mar2022 and 06Apr2022): This is a follow-up report from Product Quality Group providing investigation results.   No follow-up attempts are possible. No further information is expected.