MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD 5ML SYRINGE; SYRINGE, PISTON

Model Number SYRINGE 5ML LL TIP BULK CONVENIE

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Fluid leakage past the first and second rib of bd 5ml syringes.Fda safety report id# (b)(4).

• Brand Name: BD 5ML SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; canaan CT 06018
• MDR Report Key: 13425971
• MDR Text Key: 285179219
• Report Number: MW5107154
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• 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: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SYRINGE 5ML LL TIP BULK CONVENIE
• Device Catalogue Number: 309703
• Device Lot Number: 1208627
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other