Sex: U
Vaccine: PNC13
Symptoms: Device breakage, Device defective, Device malfunction, Syringe issue, Wrong technique in device usage process
Clinical narrative: the top of the syringe separated from the body of the syringe that contained the vaccine. It kind of broke off; the top of the syringe separated from the body of the syringe that contained the vaccine. It kind of broke off; When she tapped on the syringe, the part that houses where the needle would go, the top of the syringe separated from the body of the syringe that contained the vaccine; The initial case was missing the following minimum criteria: Product complaint only. Upon receipt of follow-up information on 27Dec2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative and product quality group.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Lot number: DX8501, Expiration Date: 31Jan2023) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MALFUNCTION (non-serious), DEVICE BREAKAGE (non-serious), outcome "unknown" and all described as "the top of the syringe separated from the body of the syringe that contained the vaccine. It kind of broke off"; WRONG TECHNIQUE IN DEVICE USAGE PROCESS (non-serious), outcome "unknown", described as "When she tapped on the syringe, the part that houses where the needle would go, the top of the syringe separated from the body of the syringe that contained the vaccine".  Additional information: They went to vaccinate a baby with Prevnar 13. The medical assistant went to mix up the Prevnar 13 solution in a refilled syringe. When she tapped on the syringe, the part that houses where the needle would go, the top of the syringe separated from the body of the syringe that contained the vaccine. Per product complaint group, Brief complaint description: Issue: broken a the neck. Reasonably Suggest Device Malfunction? Yes, Severity of Harm: S1; Complaint Class: Container; Complaint Sub-Class: Container Broken/Cracked During Prep/Use. Root Cause: Process Related: No; Final Confirmation Status: Confirmed; Vendor Related: Yes; Lot-Specific Trend Identified: No; Lot Trend Assmt. & Rationale: Fill Lot DJ2753 was packed into packaged Lot: DX8303. A review for priors was performed on 26 Apr 21 according to the following search criteria: Complaint Class is any of: Container. Quick Criteria: Include Closed Records. Result: No additional complaints were returned. An evaluation of the complaint history confirms that this is the first reported complaint for Filled Batch DJ2753 for Complaint. Class: Container. A lot specific trend was not identified, therefore, the scope of this complaint will be limited to Fill lot DJ2753. Pfizer are currently monitoring complaints reporting broken tips under PR# 5837688.; Lot Trend Actions Taken: Unk; Other Trend Identified? No; Other Trend Assmt. & Rationale: Complaints for this defect are being monitored. Refer to PR# 5837688. The scope of this historic review was expanded to include a review of the syringe barrel lots used in the manufacture of Fill lot DJ2753.; Site Sample Status: Not Received; Summary of Investigation from division was: The initial scope of this investigation will be Fill Lot DJ2753, there are no other batches in scope. An NTM is raised by Pfizer Puurs; Refer to PR 5799252 after assessment of the complaint it was determined that a report is required. Batch/Process Record Review: No Findings in relation to the reported complaint. Controls are in place to detect and prevent the reported defect; machine detects cracks in the syringe barrel and detects for empty and underfilled syringes and missing tip caps. Reserve Sample Evaluation: No defects were observed related to the reported complaint. Complaint sample evaluation: 1 syringe was received, no carton. The syringe contained about 1 cm of suspension. The suspension was normal looking and homogeneous after shaking. The rubber tip cap was missing. The needle was missing. The rubber plunger was at starting position. The plunger rod was firmly attached. The tip was broken off and missing. The luer lok was broken off. The complaint was confirmed. Refer to PR 5789496.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. No quality issues were identified as result of this complaint. Conclusion:Updated on 02Mar2022 by withheld: Severity has been corrected to S3 (See PR# for additional information). Additional review of the Annual Product Review is now required. The complaint for a broken tip during use 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 DX8303. 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 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 in PR#. The complaint for a broken tip during use 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 DX8303. 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 process determined that a 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. Broken tip complaints are monitored by Pfizer in PR#.  Lot-Specific Trend Identified: No . No follow-up attempts are needed. No further information expected.  Amendment: This report is being submitted to amend previously reported information. This follow-up report is being submitted to allow appropriate reporting to health authorities. This case involves a device malfunction. Additional information received on 16Mar2022 from Pfizer Product Quality Complaint group included additional investigation results.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.