Received Jul 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LN4931 | — |
how you have to twist the little cap, it came off and I guess the glass from the Prevnar because it broke off and it is stuck in the part where the needle goes in; The initial case was missing the following minimum criteria: Info not qualifying for AE reporting - Product Complaint: no indication that the consumer experienced an event under Product Prevnar 20. Upon receipt of follow-up information on 16Jul2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non 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: LN4931, Expiration Date: 31Jul2026) for immunisation. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "how you have to twist the little cap, it came off and I guess the glass from the Prevnar because it broke off and it is stuck in the part where the needle goes in". The reporter considered "how you have to twist the little cap, it came off and i guess the glass from the prevnar because it broke off and it is stuck in the part where the needle goes in" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "how you have to twist the little cap, it came off and i guess the glass from the prevnar because it broke off and it is stuck in the part where the needle goes in" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Follow-up (16Jul2025): This is a spontaneous follow-up report received from product quality group. Updated information: reportability assessment.