Received Oct 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | MA2502 | — |
There is a clear part below that that connects to the medication, and it broke in 2, it snapped; 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, single (Lot number: MA2502, Expiration Date: 31Oct2026) for immunisation, Device Lot Number: MA2502, Device Expiration Date: 31Oct2026. 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 "There is a clear part below that that connects to the medication, and it broke in 2, it snapped.". Causality for "there is a clear part below that that connects to the medication, and it broke in 2, it snapped." was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Additional information: at the very top there is a blue tip to twist off to put the needle on. There is a clear part below that that connects to the medication, and it broke in 2, it snapped. The consumer states the medication is still in it. There was no unusual force getting blue part off. Product strength and count size dispensed: 1 from box of 10. The sample of the product is available to be returned. It was also reported that one of the prefilled syringes broke when a nurse was going to give it, at the top. There is only one with a problem. NDC Number: 0005-2000-01.