MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE II INSULIN SYRINGE

Catalog Number 328325

Device Problem Break (1069)

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

Event Date 08/05/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: (b)(6).Initial reporter fax #: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd ultra-fine¿ ii insulin syringe experienced a needle that broke.The following information was provided by the initial reporter: patient uses the material for injection of vaccines for allergy.She stated that when touching the needle in the vaccine vial, it broke easily.

Manufacturer Narrative

H6: investigation summary : customer returned an image of a 0.5ml syringe.This syringe¿s needle is bent slightly to the side at its base.No signs of a syringe needle breaking were found.A review of the device history record was completed for batch# 9308326.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Based on the image received, bd was able to confirm the customer¿s indicated failure of a bent needle.Bd was unable to replicate or confirm the customer¿s indicated failure of the needle breaking.The root cause of the needle bending may be high stresses accidentally placed across the length of the needle during use.

Event Description

It was reported that the bd ultra-fine¿ ii insulin syringe experienced a needle that broke.The following information was provided by the initial reporter: patient uses the material for injection of vaccines for allergy.She stated that when touching the needle in the vaccine vial, it broke easily.

• Brand Name: BD ULTRA-FINE II INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12453098
• MDR Text Key: 270807676
• Report Number: 1920898-2021-00977
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328325
• Device Lot Number: 9308326
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR