Sex: U
Vaccine: PNC20
Symptoms: Syringe issue
Clinical narrative: when box was open the top was snapped off the glass was broken; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 09Jul2024, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP from medical information team and product quality group.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: HM0311, Expiration Date: 31Aug2025) for immunisation, Device Lot Number: HM0311, Device Expiration Date: 31Aug2025. 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 "when box was open the top was snapped off the glass was broken". Additional information: What has happened is they received the shipment of Prevnar 20 from Pfizer directly and when they opened the box, the glass was broken. The vaccines were not administered. Product Quality Group provided investigational results on 22Aug2024 for pneumococcal 20-val conj vac (dipht crm197 protein) (device constituent): The complaint for "when they opened the box, the glass was broken." of Prevnar 20 was investigated. The investigation included reviewing the involved batch records, deviation investigation, the returned complaint sample, evaluation of a retain sample, an analysis of the complaint history for the involved scope and Annual Product Review. Quantity of returned complaint sample(s):  one syringe. The reported defect was present on the returned complaint sample. The complaint is confirmed. No root cause or CAPA were identified as all reviewed records in scope of this investigation met the established requirements at time of release. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. The Issue Escalation process determined that a regulatory notification was required. The final scope was determined to be the associated lot(s) of the reported lot HM0311. The reported defect is not representative of the quality of the batch, and reported lot remains acceptable for further distribution. Site investigation: This complaint reported a Broken Tip for a Prevnar 20V syringe. Note; The description of this complaint did not report any patient harm. The GFill Lot is HG8790. Following investigation, the final scope was limited to the Fill Lot as a trend was not identified and no evidence was found to indicate that manufacturing activities at agency contributed to the reported complaint. The investigation included a review of; batch and process records, a lot history review and a reserve review for the lot(s) in scope. A review of the latest APRR (Annual Product Record Review) reports was performed RPT (2023), RPT (2019-2022). Review of Reserve APQR reports: A review of the APQR (Annual Product Quality Review) reserve chapters were performed -RPT (2023 Section) and RPT (2019- 2022 Section). No issues were identified. The complaint sample was received at Pfizer, following sample evaluation, the reported defect was confirmed (EVAL). An evaluation of the complaint history confirmed that this is the first complaint reported for this subclass for the Fill Lot HG8790. A lot specific trend was not identified. A trend was not identified for the syringe barrel lots associated with the Fill Lot for this class/subclass. A trend was not identified following a review of the complaint profile for Prevnar 20V and related products. Controls are in place to prevent/detect the reported complaint. The inspection machine has 100% detection for underfilled/empty syringes and also detects a missing tip cap and cracked barrel. Agency investigation PR# found that the root cause for defect 'broken tip' is due to defects/flaws which occur during the syringe manufacturing process followed by subsequent mechanical stress leading to tip breakage. A contributory root cause identified that there is no standardised risk based method for requesting vendor investigations from suppliers for defects reported in customer complaints. Corrective actions have been identified. The Effectiveness Checks of </= 0.5 complaints per million have passed. Refer to agency PR#. There were no issues identified during the investigation impacting product quality. A process related root cause was not identified at agency, A vendor related root cause was identified. After assessment of the complaint, it was determined that a regulatory notification  is required for this complaint. Complaints for this defect 'broken tip' are monitored by agency, refer to commitment tracking occurrence PR#. No further action is required. The Vendor will be informed of this defect as documented in PR. Device investigation: This investigation is based on the information captured in the Complaint Description. The Complaint Issue, Damaged Component, was reported. The Risk Management File was reviewed to confirm that the Hazard(s) and Hazardous Situation(s) associated with the Complaint Issue are documented in the Hazard Analysis. All complaint investigations are trended. There is no current trend alert documented.  The reporter considered "when box was open the top was snapped off the glass was broken" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "when box was open the top was snapped off the glass was broken" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).