Sex: U
Vaccine: PNC13
Symptoms: Manufacturing issue, Syringe issue
Clinical narrative: Prevnar syringes that is broken at the neck of syringe; The initial case was missing the following minimum criteria: product compaint only with no patient receiving the product. Upon receipt of follow-up information on 11Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporters (Consumer or other non HCP) from product quality group for a Pfizer sponsored program.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Lot number: DX8301, Expiration Date: 31Jan2023) as dose number unknown, 0.5ml 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 "Prevnar syringes that is broken at the neck of syringe". Additional information: NDC number of Prevnar 13 was 0005197101. The reporter (site coordinator) stated that they have one of the Prevnar 13 syringes that was broken at the neck of syringe. No patients have received the product. They pulled out the box of Prevnar 13 from the fridge and when they opened the box it fell out of the container/canister onto the counter. They brought the product to her right away and it still had liquid in it. The counter was tall. They didn't know what to do with it and so they called. As far as they could tell it broke when it fell out of the package on to the counter. The reporter assumed it was already damaged due to this never happening before. A sample of the product was available to be returned. Reporter informed that a prepaid mailer may be sent in 3-10 business days.  Product Quality Group provided investigational results on 07Oct2021 for pneumococcal 13-val conj vac (dipht crm197 protein): The complaint of "the syringe broke after falling onto the counter" for PREVNAR 13V PFS SUSPENSION 0.5MLX10 was investigated by the manufacturing site. The Agency 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. 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. The complaint for "broken after falling onto the counter" of PREVNAR 13V INJECTABLE was investigated. The investigation included reviewing the involved batch records, deviation investigation, complaint sample, 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 DX8301. 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 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. 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. Investigation classified the root cause as related to Material.  No follow-up attempts are possible. No further information is expected.