Received May 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC15 | PNEUMO (VAXNEUVANCE) | MERCK & CO. INC. | 1 | Y019380 | — |
no injury to patient, No additional AE; a broken finger flange for VAXNEUVANCE during administration on 05/20/2025, "near the barrel at the end of the plunger" for the broken finger flange; a broken finger flange for VAXNEUVANCE during administration on 05/20/2025, "near the barrel at the end of the plunger" for the broken finger flange; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-May-2025, the patient was vaccinated with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) (lot #Y019380, expiration date reported as and upon internal validation confirmed to be 28-May-2027) (dose, route of administration and vaccination site were not reported) administered for prophylaxis. The nurse reported a broken finger flange for with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) during administration (poor quality device used). The location was described as "near the barrel at the end of the plunger" for the broken finger flange (syringe issue). Defective unit has been set aside for return and photos were provided. No injury to patient was confirmed (no adverse event). No other information was available. No additional adverse event (AE) and no additional product quality complaint (PQC) was noted.; Sender's Comments: Priority : 5 , Is case serious : No , number : , number : , number : , number : 500UW00000bQFPWYA4|28052025230010|6658 , Central date : 2025-05-29 , Classification :, Attachment description : Call , Safety case number : , case number : , interaction number : , Integration log UniqueID : 500UW00000bQFPWYA4|28052025230010|6658 , Service cloud CaseID : 500UW00000bQFPWYA4