MAUDE Adverse Event Report: BECTON DICKINSON BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE, 12.7MM 3/10ML 1/2" 30G; SYRINGE, PISTON

Model Number 08290

Device Problem Material Twisted/Bent (2981)

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

Event Date 08/01/2021

Event Type  malfunction  

Event Description

I took the protective sheathe off my becton dickenson ( bd) insulin syringe (with bd ultra-fine needle 127mm 3/10ml 1/2' x 30g) and found the needle bent at 40 degrees of vertical.This is a common occurrence with this model syringe.When i open their syringes, i find 12% to be off vertical to this degree.Many others are bent, but to a lesser degree.I have communicated with bd by phone and snail mail regarding this issue with no promise to 'fix' this manufacturing problem.They have sent me a two replacement boxes distributed by my local pharmacy, which is (b)(6) at (b)(6).This is a problem i been facing for the past 5 years or more.I have to bend the needle back to vertical using the rubber cap on the bottle of insulin.Bd have demonstrated no interested in correcting it manufacturing process.The 'test date' asked for below is every 2-3 days a week.I make no error when unsheathing, a process i have practiced since the launch of bd's disposable syringe in 1961.I been type 1 diabetic since (b)(6) of 1958.Fda safety report id # (b)(4).

• Brand Name: BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE, 12.7MM 3/10ML 1/2" 30G
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 12294039
• MDR Text Key: 266194193
• Report Number: MW5103081
• 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: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 08290
• Device Lot Number: 1018138 A
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 95