Received Dec 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | MG7421 | — |
a piece of plastic inside of it in with where the product is; This is a spontaneous report received from an Other HCP from product quality group. This report involves pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: MG7421, Expiration Date: 30Sep2026) for immunisation. The following information was reported: PRODUCT CONTAMINATION PHYSICAL (non-serious) with onset 20Nov2025, outcome "unknown", described as "a piece of plastic inside of it in with where the product is". Causality for "a piece of plastic inside of it in with where the product is" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Additional information: Reporter stated, "I am calling from a pharmacy and I have a Prevnar 20 and was going to administer it the other day and it has a piece of plastic inside of it in with where the product is. So, we couldn't use it. So, I need to know as far as one, we need to replaced and two, what we should be doing is sending this back to you or not." Reporter confirmed it was not administered. Date of incident was 20Nov2025. A sample of the product was available to be returned. Packaging sealed and intact. When probed if the piece noted in the original container or noted after drawing out the solution, reporter stated, "No, when I opened the box to administer the prefilled syringe, it was inside of this." When probed if the pieces were floating or sink to the bottom, reporter stated, "It was floating." When probed if reporter will able able to provide the shape, size or color of pieces, reporter stated, "It's white, you want to know size, shape it's not any specific shape, it's triangular maybe."