MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 3ML L/L NO NEEDLE 9657; SYRINGE, PISTON

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Patient reported that syringe was leaking when she injected last week.Where the needle and syringe meet.Pt stated received most of her medication and she noticed it when she was already injecting her dose and didn't want to take the needle out and attach another needle.Patient wanted us to be aware of issue.No attacks reported.No adverse events reported.Unknown if syringe is available for retrieval.No further information provided.Reported to (b)(6) by patient/ caregiver.

• Brand Name: SYRINGE 3ML L/L NO NEEDLE 9657
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 10118533
• MDR Text Key: 194120526
• Report Number: MW5094827
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1