MAUDE Adverse Event Report: PFIZER INC. VACCINATION NEEDLE FOR PFIZER - BIONTECH COVID 19 VACCINE; SYRINGE, PISTON

Lot Number ER8732

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/15/2021

Event Type  malfunction  

Event Description

Working as site manager at the covid vaccination clinic, i was told by my medical assistant that the needles that housed the vaccine that we received in the morning from the hospital pharmacy were defective.The needle separated from the syringe after administering the vaccine and the medical assistant had to pull the separated needle out of the patient's arm.The patient was not aware that the needle was left behind in her arm because she was not looking while she was being vaccinated.I contacted the pharmacy 3 times about the needles and was advised to just give another vaccine.I was told that the needles were new and that they came already attached to the syringe.In return, i told all the vaccinators to make sure that the needles were tight on the syringe, but when we turned the needles, they never came to a complete stop, they would just keep turning, i asked that they did not use those needles again for my remaining batches for the rest of the day.I was told that the pharmacy discarded the new needles.

• Brand Name: VACCINATION NEEDLE FOR PFIZER - BIONTECH COVID 19 VACCINE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): PFIZER INC.; 235 east 42nd street; new york NY 10017
• MDR Report Key: 12238301
• MDR Text Key: 263826634
• Report Number: 12238301
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: ER8732
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1