Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LK6650 | — |
they had a air bubble in the medication and the nurse was tapping the needle to get the air bubble out and it broke.; they had a air bubble in the medication and the nurse was tapping the needle to get the air bubble out and it broke.; This is a spontaneous report received from a Consumer or other non HCP from 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, 0.5ml single (Lot number: LK6650, Expiration Date: 31May2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), DEVICE BREAKAGE (non-serious), outcome "unknown" and all described as "they had a air bubble in the medication and the nurse was tapping the needle to get the air bubble out and it broke.". Additional information: Transferring agent started, "I just have a customer that called, and it was the Prevnar 20, they had an air bubble. She said for Prevnar 20 they had a air bubble in the medication and the nurse was tapping the needle to get the air bubble out and it broke.". When paraphrased the concern, reporter stated, "Yes, it broke completely." Product Quality Group provided investigational results on 22Apr2025 for pneumococcal 20-val conj vac (dipht crm197 protein) (device constituent): The complaint for "they had a air bubble in the medication" of Prevenar 20 was investigated.The investigation included reviewing the involved batch records, deviation investigation, the evaluation of a retain sample, an analysis of the complaint history for the involved scope and Annual Product Review. A complaint sample was not returned. The complaint is not confirmed. No root cause or CAPA were identified as the complaint was not confirmed. 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 (NTM) process determined that no regulatory notification was required. The final scope was determined to be the associated lot(s) of the reported lot LK6650. The reported defect is not representative of the quality of the batch, and reported lot remains acceptable for further distribution. Site Investigation (Puurs):Container Broken/Cracked During Prep/Use. The complaint for "the nurse was tapping the needle to get the air bubble out and it broke." of Prevenar 20 was investigated. The investigation included reviewing the involved batch records, deviation investigation, evaluation of retain sample, an analysis of the complaint history for the involved scope and Annual Product Review. A complaint sample was not returned. The complaint is not confirmed. No root cause or CAPA were identified as the complaint was not confirmed. 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 (NTM) process determined that no regulatory notification was required. The final scope was determined to be the associated lot(s) of the reported lot LK6650. The reported defect is not representative of the quality of the batch, and reported lot remains acceptable for further distribution. Site Investigation: Bubbles/Foamy - Liquid. The complaint reported "air bubble" for a Prevnar 20V syringe.?The Fill Lot is LE1000. The final scope was limited to the Fill Lot and its component lots (Aluminium phosphate and Buffer lot) as a trend was not identified and no evidence was found to indicate that manufacturing activities contributed to the reported complaint. The investigation included a review of batch records and process records, a lot history review and a reserve review for the lot(s) in scope. An evaluation of the complaint history confirms that this is the first complaint for the Fill Lot for this complaint subclass. A Lot specific trend was not identified. Controls are in place to prevent/detect the reported complaint; EISAI inspection for particulate matter, In process testing of turbidity, AQL inspection for abnormal colour (low/high turbidity) and product appearance release testing. A sample or photo was not received. A review of the latest APQR (Annual Product Quality Review) reports was performed - RPT-193056 (2019-2022) and RPT-218189 (2023). No trends were identified for subclass Adverse Event MD/MDCP. Review of Reserve APQR reports: A review of the APQR (Annual Product Quality Review) reserve chapters were performed - RPT-215231 (2023 Section 9.0) and RPT-194694 (2019-2022 Section 9). No issues were identified.There were no issues identified during the investigation impacting product quality. The complaint is not confirmed and is not process related. A root cause was not identified, and no corrective/preventative actions are required.? The reported defect is not representative of the quality of the batch, and lot LE1000 remains acceptable for further distribution.? An issue escalation was not raised and regulatory notification is not required. No further action is required. Site Investigation: Container Broken/Cracked During Prep/Use. The complaint reported "the needle broke completely" for a Prevenar 20V syringe.?The Fill Lot is LE1000. 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 contributed to the reported complaint. The investigation included a review of batch records and process records, a lot history review and a reserve review for the lot(s) in scope. No complaint sample or photo was returned for this complaint. Therefore, this complaint is not confirmed. An evaluation of the complaint history confirms that this is the first complaint for the Fill Lot for this complaint subclass. 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 review of the latest APRR (Annual Product Record Review) reports for Prevenar 20V Drug Product was performed for 'Product Complaints' and 'Reserve Samples'. No trends or issues were identified in relation to this complaint. Refer to RPT-246679 (2024), RPT-215256 (2023) and RPT-194382 (2019-2023). Controls are in place to prevent/detect the reported complaint; The EISAI inspection machine has 100% detection for underfilled/empty syringes and also detects a missing tip cap and cracked barrel. There were no issues identified during the investigation impacting product quality. The complaint is not confirmed and is not process related. A root cause was not identified, and no corrective/preventative actions are required. Following completion of the investigation it is determined that a regulatory notification is not required for this complaint. The reported defect is not representative of the quality of the batch, and lot LE1000 remains acceptable for further distribution.Device Investigation: This investigation is based on the information captured in the Complaint Description and Argus Report. Two distinct Complaint Issues of "Cartridge/Syringe Barrel Broken During Prep/Use" and "Product Appearance - Bubbles/Foamy Liquid" were reported. However, these two distinct Complaint Issues map to the same Hazards/Hazardous Situations. 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 (INX100323906, Version 7.0). All complaint investigations are trended. There is no current trend alert documented.