Sex: U
Vaccine: PNC13
Symptoms: Device breakage
Clinical narrative: trying to screw the top on the Prevnar vial and the glass broke; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 01Jun2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative and product quality group.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Lot number: DW3410, Expiration Date: 31Mar2023) 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 "trying to screw the top on the Prevnar vial and the glass broke".  Additional information: The staff was trying to screw the top on the Prevnar vial and the glass broke. It was a faulty vial. Looking for any recourse as they couldn't use it. There were no patients involved. NDC is 005-1971-01. Investigation results Conclusion: This complaint reported broken syringe tip for a Prevnar 13V syringe. The Fill Lot is DN4738. 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 and reserve review for the lot in scope. An evaluation of the complaint history confirms that this is the first 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. The complaint sample/ photo was not returned at the time of report completion; the reported complaint was not confirmed. Broken syringe tip may be 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. There are controls in place at Pfizer to prevent/detect this defect; the Agency inspection machine detects a missing tip cap, cracks in the barrel and under fill / 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 report is required. Complaints for this defect broken tip are monitored by Agency, any required corrective actions will be documented. Refer to commitment tracking occurrence. The complaint of broken syringe tip for PREVNAR 13V PFS SUSPENSION 0.5MLX10 was investigated by the manufacturing site. Agency Investigation: An NTM is raised by Pfizer, after assessment of the complaint it was determined that a report is required. The findings of the Agency 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 complaint sample was received at Pfizer, the complaint was confirmed after sample evaluation by Pfizer. 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 Fill Lot (refer to related lots grid) as no evidence was found to indicate that manufacturing activities at Agency contributed to the reported complaint. Investigation: The complaint for "broken tip" of PREVNAR 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. The final scope was determined to be the associated lot(s) of the reported lot DW3410. 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. Agency 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 report 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. Additionally, this complaint was also investigated by the Agency and they concluded that, based on the previous investigation of broken syringe tip, the root cause was identified to be related to the manufacturing of the glass syringes, resulting in inherent weakness in the glass. RA classified the root cause as related to Material.  No follow-up attempts are possible. No further information is expected.