Received Mar 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LC5484 | — |
the whole top section of the luer lock broke off the syringe; This is a spontaneous report received from an Other HCP from product quality group. A patient (age and gender not provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LC5484, Expiration Date: 31Jan2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "the whole top section of the luer lock broke off the syringe". Additional information: The reporter said that while opening a box, a medical assistant grabbed a dose, and the whole top section of the luer lock has broken off the syringe. The reporter mentioned that this is not her first rodeo with this issue. The luer lock breaking off the syringe has occurred with other pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20) vaccines. No patients were involved with any of the PREVNAR 20 vaccines that had this issue. Causality for "the whole top section of the luer lock broke off the syringe" was determined associated to device constituent of pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (malfunction).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400237868 same reporter/product/PC, different lots;US-PFIZER INC-202400266262 same reporter/product/PC, different lots;US-PFIZER INC-202400272234 same reporter/product/PC, different lots;