MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD 10 ML SYRINGE LUER-LOK TIP; SYRINGE, PISTON

Lot Number 9273092

Device Problems Contamination (1120); Crack (1135); Leak/Splash (1354); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 11/24/2020

Event Type  malfunction  

Event Description

After compounding a radiopharmaceutical, the isotope was drawn up into a bd10ml syringe, punctured the rubber stopper of the vial and pressed the plunger of the syringe.The syringe had a crack in the barrel which the radioactive isotope squirted out of and contaminated the inside of the caci hood.Our nuclear medicine department has found numerous defective syringes ranging from 3 ml, 5 ml, and 10 ml sizes.This is the first time one has produced a contamination of equipment or personal.Fda safety report id#: (b)(4).

• Brand Name: BD 10 ML SYRINGE LUER-LOK TIP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 11574372
• MDR Text Key: 242753652
• Report Number: MW5100281
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903029952
• UDI-Public: (01)00382903029952
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/23/2021

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: No Information
• Device Lot Number: 9273092
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other