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 11/11/2019

Event Type  malfunction  

Event Description

I have noticed that all of our supplies have changed.The pre-packaged 3ml syringes used to come with 18 1 inch needles on them.They now come with 20 1 inch g.This makes it harder to draw up the medications.The quality has gone down in these products as well.The needles could be a safety risk as some of them are not tight to the syringe.Also, when i have to change them to the 25 1 inch, after i draw them up, i sometimes end up throwing away the entire syringe because the new needle top doesn't lock in tight to the teeth of the syringe, therefore wasting meds and supplies.I double check all of them for tightness before giving them to the providers to use, however, my worry is if they give the injection and the top comes off or the needle doesn't stay on tight, it could harm the patient and/or cause needle sticks to the provider.The other issue is there are no longer any 5ml or 10ml syringes.There are now only 3ml, 6ml, 12ml syringes.The providers are not happy with this change either.Using the bigger syringes makes it harder to push the medication when they could get by with a smaller syringe.Please let me know if there is any way to get our old supplies back.In the 10 years i have worked here, i have never had any issues with supplies until now.

• 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: 9847392
• MDR Text Key: 183904267
• Report Number: 9847392
• 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: Health Professional
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1