Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LP4947 | — |
when nurse went to close safety needle, caller states she is not sure which part, but the part of the prefilled syringe where the needle is put on completely came off, it almost looks like a clean cut; when nurse went to close safety needle, caller states she is not sure which part, but the part of the prefilled syringe where the needle is put on completely came off, it almost looks like a clean cut; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 19Sep2025, this case now contains all required information to be considered valid. This is a spontaneous report received from an Other 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: LP4947, Expiration Date: Aug2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) and all described as "when nurse went to close safety needle, caller states she is not sure which part, but the part of the prefilled syringe where the needle is put on completely came off, it almost looks like a clean cut". Additional information: A nurse was administering the vaccine and when nurse went to close safety needle, caller states she is not sure which part, but the part of the prefilled syringe where the needle is put on completely came off, it almost looks like a clean cut. States this occurred right after administering it to the patient and caller confirms the patient did get the appropriate dose. It occurred when trying to cap the needle. She does not have patient details to provide stating she does not know who the patient was. States the needle is still attached to part of it and asking if requested by quality department, should the needle be removed before sending back. The sample is available to be returned. Causality for "when nurse went to close safety needle, caller states she is not sure which part, but the part of the prefilled syringe where the needle is put on completely came off, it almost looks like a clean cut" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).