MAUDE Adverse Event Report: BECTON DICKINSON 10CC SYRINGE LUER LOK 20GX1 DETACHABLE; SYRINGE, PISTON

Catalog Number 15-9644-4

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A user facility clinic manager reported to customer service that there were cracks in the barrel of the syringe due to a potential loose seal and causing contents / blood to squirt out when pushing contents in.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: 10CC SYRINGE LUER LOK 20GX1 DETACHABLE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 17536868
• MDR Text Key: 321268600
• Report Number: MW5143751
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2022

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?: No
• Device Catalogue Number: 15-9644-4
• Device Lot Number: 2070214
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1