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

Lot Number 0041240 C

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2020

Event Type  malfunction  

Event Description

Bd insulin syringe needle was bent.Unable to use syringe for insulin as it would not extract the insulin from the bottle.(this is at least the fourth time i've had bd syringes that were found to be bent once the packaging was opened.) lot # dd41240 c, manufactured 2020-03-01, expiration 2026-02-28.Fda safety report id# (b)(4).

• Brand Name: BD INSULIN SYRINGES ULTRA-FINE NEEDLE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 10748386
• MDR Text Key: 213876288
• Report Number: MW5097501
• 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: 10/25/2020
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 0041240 C
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR