MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD INSULIN SYRINGES WITH BD ULTRA-FINE NEEDLE; SYRINGE, PISTON

Model Number NDC/HRI# 08290-8468-01 - 328468

Device Problem Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 07/03/2021

Event Type  malfunction  

Event Description

Needles of insulin syringes are defective and bend 50% of the time.The manufacturer bd is so cynical that did not test the bend needle syringe that i sent them.Fda safety report id# (b)(4).

• Brand Name: BD INSULIN SYRINGES WITH BD ULTRA-FINE NEEDLE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 12301558
• MDR Text Key: 266096124
• Report Number: MW5103124
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NDC/HRI# 08290-8468-01 - 328468
• Device Lot Number: 1046952 B
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 68