Sex: U
Vaccine: PNC13
Symptoms: Device malfunction, Syringe issue
Clinical narrative: She went to put the needle on the hub to give the dose, and she tried to unscrew the cap when the whole hub broke off at the neck.; She went to put the needle on the hub to give the dose, and she tried to unscrew the cap when the whole hub broke off at the neck.; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Pfizer), via an unspecified route of administration on an unspecified date (Lot Number: DX8301; Expiration Date: 31Jan2023, NDC number: 0005197101, 05 ml) as 0.5mL, single for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, one of the clinic nurses was taking the vaccine out of the fridge. She went to put the needle on the hub to give the dose, and she tried to unscrew the cap when the whole hub broke off at the neck. There was exposed glass so it was unable to be given. The nurse was wanting to report a quality issue with Prevnar and wanting credit for it. The sample of the product was available to be returned. Packaging was sealed and intact.   Investigation results: Description of Complaint: Description of complaint: There is a nurse on the line reporting a PQC for Prevnar 13. Product-Description: Prevnar 13V PFS Suspension 0.5mlX10, Injectable, Lot: DX8301, expiration: 31Jan2023, NDC Number: 0005197101. Brief Complaint Description: She went to put the needle on the hub to give the dose, and she tried to unscrew the cap when the whole hub broke off at the neck. There was exposed glass so it was unable to be given. Product strength and count size dispensed: 0.5mL, 1 vial. The sample of the product was available to be returned. Packaging was sealed and intact. Reasonably Suggest Device Malfunction: Yes. Severity of Harm: S3. Process Related was No. Final Confirmation Status was Not Confirmed. Vendor Related was No.  Root Cause Analysis/Identif: The withheld 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. However, without complaint sample and based on the available information it is not possible to perform a more profound investigation and/or root cause analysis. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. PGS withheld concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. No evidence was found to indicate that manufacturing activities at contributed to the reported complaint. In the absence of a returned complaint sample, a definitive root cause was not identified for the reported complaint. Note: 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. Impact Analysis: Following review of the investigation results based on the final scope, there is no evidence that manufacturing activities. Corrective / Preventive Action: 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, therefore no corrective and preventative actions were identified. This complaint reported a broken syringe tip. The correct classification and priority were assigned to this complaint. Summary of Investigation: The initial scope of the withheld investigation is limited to the lots documented in the related lots grid. An NTM is raised by Pfizer withheld; Refer to PR withheld, after assessment of the complaint it was determined that a withheld is required. The findings of the withheld 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: A sample/photo were not returned for the complaint at the time of report completion. 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 GC Fill Lot (refer to related lots grid) as no evidence was found to indicate that manufacturing activities at withheld contributed to the reported complaint. Conclusion: The complaint for hub broke off at the neck of Prevnar 13V Injectable was investigated. The investigation included reviewing the involved batch records, deviation investigation, 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 DX8301. 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. 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 (withheld)was required. The reported defect could not be confirmed on the evaluation of the retain sample. No root cause or CAPA were identified as the complaint was not confirmed. This complaint reported broken syringe tip for a Prevnar 13V syringe. The Fill Lot is DJ2750. Following investigation, the final scope was limited to the withheld Fill Lot as a trend was not identified and no evidence was found to indicate that manufacturing activities at withheld 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 withheld to prevent/detect this defect; the withheld inspection machine detects a missing tip cap, cracks in the barrel and underfill / empty syringes. There were no issues identified during the investigation impacting product quality. A process related root cause was not identified at withheld and no corrective/preventative actions are required.  No follow-up attempts are needed. No further information is expected.