MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE; SYRINGE, PISTON

Lot Number 2263287

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 04/17/2023

Event Type  malfunction  

Event Description

Malfunction.

• Brand Name: SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 16818291
• MDR Text Key: 314111886
• Report Number: MW5117072
• Device Sequence Number: 1
• Product Code: FMF
• 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: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 2263287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 76 KG