Sex: U
Vaccine: PNC13
Symptoms: Defaecation urgency, Syringe issue
Clinical narrative: the neck of your vaccine snapped;  defective vaccine; actual impact to the patient is limited to a delayed dose (S1); This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVENAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot Number: DR1779; Expiration Date: Feb2023) as dose number unknown, single for immunization. The patient's medical history and concomitant medications were not reported. The patient reported that the neck of the vaccine snapped; defective vaccine. The patient stated, "One of the necks, the glass neck on one of the Prevnar 13 snapped. The nurse connected a lower lock needle under the lower lock and when she went to put cover off the needle the neck of your vaccine snapped.  Investigation result from Product Quality Group: Description of Complaint:  Complaint Issue: Broken at the neck (Lot: DR1779; Batch Expiry: Feb2023). Reasonably Suggest Device Malfunction: Yes; Severity of Harm: S1. Summary of Investigation: The initial scope of the investigation is limited to the lots documented in the related lots grid.  The findings of the 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 sample was evaluated at Pfizer and did confirm the reported complaint. 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 contributed to the reported complaint. Root Cause Analysis/Identif: No evidence was found to indicate that manufacturing activities at Withheld contributed to the reported complaint. The returned sample confirmed the reported defect. 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 contributed to the defect reported in this complaint. All reviewed records for the involved batch indicated that the batch met the established requirements at time of release Impact Analysis: Following review of the investigation results based on the final scope, there is no evidence that manufacturing activities contributed to the reported complaint. A lot specific trend was not identified. The reported complaint is not representative of the quality of the batch and the batch remains acceptable. 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). Corrective/Preventive Action: Following investigation, no evidence was found to indicate that manufacturing activities contributed to the reported complaint, therefore no corrective and preventative actions were identified. Complaint Sample Evaluation:(Parent) Sample_Status: Sample Availability Unknown. Site Sample Status: Not Received; Return Sample Evaluation One syringe received. No defects found on label. There was only dried up suspension inside the syringe. The rubber tip cap was missing, the needle was present, the rubber plunger was in position after ejecting part of a dose and the plunger rod was firmly attached. The tip of the syringe was broken off and inside the needle hub. There was dried up suspension at the inside of the barrel. Confirmed Complaint Sample Defect?: Yes. Impact assessment: 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. 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. Conclusion: The complaint for "glass neck snapped" 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 and Annual Product (Quality) Review. The final scope was determined to be the associated lot(s) of the reported lot DR1779. 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. Site 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 (BPDR) 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.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.