MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD PLASTIPAK SYRINGE WITH NEEDLES (3ML); SYRINGE, PISTON

Lot Number 0337969

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 05/07/2021

Event Type  malfunction  

Event Description

Bd plastipak 3ml syringe with needle attached.Needle popped off of syringe and created waste of diluent used in reconstituting covid 19 vaccine.Pharmacist could not determine how much diluent had already been placed into the vial, so the vial of covid vaccine had to be wasted as well.Fda safety report id # (b)(4).

• Brand Name: BD PLASTIPAK SYRINGE WITH NEEDLES (3ML)
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 11816930
• MDR Text Key: 250737545
• Report Number: MW5101308
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 08290309574
• UDI-Public: 08290-3095-74
• 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: 05/10/2021

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 Expiration Date: 11/30/2021
• Device Lot Number: 0337969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2021
• 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
• Patient Outcome(s): Other