MAUDE Adverse Event Report: BECTON DICKINSON BD PLASTIPAK 3ML SYRINGE; SYRINGE, PISTON

Lot Number 0205067

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/09/2021

Event Type  malfunction  

Event Description

Bd plastipak syringe (pfizer covid -19 vaccine) treatment under emergency use authorization(eua): product in question is the 3 ml bd syringe that comes packaged with pfizer covid 19 vaccine issued by (b)(6) dshs.Fda safety report id # (b)(4).

• Brand Name: BD PLASTIPAK 3ML SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 11337349
• MDR Text Key: 232216241
• Report Number: MW5099406
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0205067
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1