Sex: U
Vaccine: PNC13
Symptoms: Syringe issue
Clinical narrative: Prefilled syringe came broken; 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: EJ4560, Expiration Date: 31Jul2023) 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 "Prefilled syringe came broken".  Additional information: Description of complaint Caller states that she is calling in regards to Prevnar 13. They had a previous order, in which one of the prefilled syringed came broken. The Top part of the syringe was broken, the part where they would attach the needle. Caller clarifies that needles do not come with the product. NDC 00005197102. Sample of the product is available to be returned. Packaging sealed and intact. Conclusion as of 03Feb2022: This complaint reported a broken syringe tip for a Prevnar/Prevenar 13V syringe. The product Fill Lot is DX7780. The investigation included a review of, batch and process records, a lot history a reserve sample re-view for the lot(s) in scope The complaint sample/photo was not returned for this complaint, the complaint is not confirmed. An evaluation of the complaint history confirmed a total of three com-plaints for the Filled Lot for complaint Class 'Container' of  which one complaint (the current com-plaint) 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 (Withheld) Fill lot and no evidence was found to indicate that manufacturing activities at (Withheld) contributed to the reported complaint.  A quality review of complaints reporting 'Broken tip' concluded that the root cause for this defect is due to an inherent weakness in the glass resulting from the syringe manufacturing process. The patient risk associated with this defect is marginal to low.  Conclusion as of 17Feb2022: The complaint for 'Top part of the syringe was broken' of Prevnar 13V Injectable was investigated. The investigation included reviewing the involved batch records, deviation investigation, evaluation of retain samples, 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 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. Agency 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. The reported defect could not be confirmed on the evaluation of retain sample. No root cause or CAPA were identified as the complaint was not confirmed.  No follow-up attempts are possible. No further information is expected.