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

Lot Number 9030501

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2019

Event Type  malfunction  

Event Description

There are no longer 5ml syringes with needles.

• Brand Name: BD 5ML SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9847390
• MDR Text Key: 183903842
• Report Number: 9847390
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 9030501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2020
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1