Sex: U
Vaccine: PNC13
Symptoms: Syringe issue
Clinical narrative: prefilled syringes that broke when they were going to administer it to patients; no patients received; This is a spontaneous report received from a contactable reporter (Other HCP) from product quality group.  A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (dipht crm197 protein) (PREVNAR 13) (Lot number: DF1307, Expiration Date: 31Aug2022) as dose number unknown, single for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "prefilled syringes that broke when they were going to administer it to patients; no patients received". Additional information: Caller, an LPN, reporting on two Prevnar 13 syringes and who explains that she was presented with 2 prefilled syringes that broke when taking the cap off the needle. She thinks this happen when they were going to administer it to patients and were about to remove the cap. Caller confirmed no patient received either product. It was explained that the actual luer lock that the needle screws into broke off on both. She discarded the needle in the sharps container but kept the vials for return. The packs were sealed and intact and there were no problem with any other syringes in the same containers.   Product Quality Group provided investigational results on 29Jun2021 for pneumococcal 13-val conj vac (dipht crm197 protein). Conclusion: The complaint for "Container Broken During Prep/Use: of "PREVENAR 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 and Annual Product (Quality) Review. The final scope was determined to be the associated lots of the reported lot DF1307. 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. 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. Broken tip complaints are monitored by Pfizer.   Reasonably Suggest Device Malfunction was Yes. Severity of Harm was S1. Root Cause Analysis/Identification: 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. Impact Analysis: 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 was required. A report will be issued. 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 Reserve sample evaluation completed on 28Sep2020. Quantity of reference samples reviewed: 1 carton and 10 syringes. Examination results: 1 carton and 10 syringes were visually inspected. No defects were detected. The complaint history has been reviewed for the reported batch. One similar complaint has been received in the past three years, no lot trend signal could be noticed. Site Sample Status was Received at the Site on 27May2021. Visual Complaint Sample Evaluation Completed on 28May2021. Return Sample Evaluation: One syringe was received, without carton or blister. No defects were found on the label. The syringe was empty. The rubber tip cap and needle were missing. The plunger was in position after ejecting part of a dose and the plunger rod was firmly attached. The tip was broken off and it was missing. The luer lock was in loose. Summary of investigation: The initial scope of this investigation will be Fill Lot CM3131 and the syringe barrel lots involved in the manufacture of fill Lot CM3131. Following investigation, no other batches were identified to be in scope. Regulatory Assessment: The complaint was reported from the market, a report is required, refer to withheld NTM #. Batch/Process Record Review: No Findings in relation to the reported complaint. There are controls in place with regard to Pfizer withheld processes to prevent/detect this defect; the agency inspection machine detects a missing tip cap, cracks in the syringe barrel and detects for empty and underfilled syringes. Reserve Sample Evaluation: No defects were observed. Trend/Complaint History: A lot specific trend was not identified for the Fill Lot or for the Syringe barrel lots used in the manufacture of fill lot CM3131. Complaint Sample Evaluation: A complaint sample was returned to Pfizer withheld. Root Cause: The true root cause for this complaint could not be conclusively determined based upon the available information, as the complaint sample was not returned for evaluation at the time of the report completion. 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 Withheld contributed to the defect reported in this complaint. Impact Analysis: A trend was not identified for the Fill Lot or syringe barrel lots for syringes with broken tips, there is no impact to the quality of the batch. Breakages of this type (broken at the 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 by agency, refer to #. Conclusion: Following investigation of this complaint which reported a syringe with a broken tip for a Prevnar 13V syringe for Pack Lot /Fill Lot DF1307/CM3131, no evidence was found to indicate that this complaint occurred as a result of manufacturing activities at Pfizer withheld. The investigation included a review of batch records, manufacturing investigations, reserve review and a lot history review for the Fill Lot and associated syringe barrel lots. A trend was not identified for Fill Lot CM3131 or the associates syringe barrel lots. Withheld perform formulation and filling activities for the fill lot. Therefore, the final scope of the investigation was limited to withheld Fill Lot CM3131 and the associated syringe barrels lots, refer to related lots grid. A sample was returned to Pfizer Withheld. Refer to Pfizer Withheld sample evaluation. The complaint is confirmed. Following investigation, a process related root cause was not identified at Withheld for this reported complaint. There are controls in place with regard to Pfizer Withheld processes to prevent/detect this defect; the agency inspection machine detects a missing tip cap, cracks in the barrel and underfill / empty syringes. 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. There is no impact on product quality and patient safety. A trend was not identified. Breakages of this type (broken at the tip) are catastrophic and render the syringe unusable. Consequently, the actual impact to the patient is limited to a delayed dose (S1). As this is a know issue a report is required, refer to agency NTM #. Complaints for this defect 'broken tip' are monitored by withheld, refer to #. No evidence was found that manufacturing activities at Withheld contributed to the reported complaint. No change to the initial scope was required following review of the batch and process records. An evaluation of the complaint history confirmed a total of 3 complaints for the filled lot for complaint class 'Container' of which 2 complaints were reported for complaint subclass 'container broken/cracked during prep/use'. A lot specific trend was not identified; therefore, the scope of this investigation is limited to lots documented in the related lots grid and the material information grid. Withheld are currently monitoring complaints reporting 'broken tips'.  No follow-up attempts are needed. No further information is expected.