MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD LUER-LOK; SYRINGE, PISTON

Device Problems Inadequate User Interface (2958); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 11/12/2019

Event Type  malfunction  

Event Description

The 3ml syringes used to come with 18 1 inch needles on them.They now come with 20 1 inch g, which make it tough to draw up.Especially, with thick steroid medication.You cannot tighten the needles, so when drawing up medication the needle falls off onto the floor.Then it all is wasted and i have to start all over.New needles cannot be locked, because there are no threads on the syringe and needle.There are no longer 5ml or 10ml syringes, which makes it difficult to inject because of the greater pressure.There are now only 3ml, 6ml, 12ml syringes.

• Brand Name: BD LUER-LOK
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9847406
• MDR Text Key: 183904547
• Report Number: 9847406
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2020
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/18/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1