MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31G 6MM; PISTON SYRINGE

Catalog Number 328521

Device Problem Break (1069)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/03/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 1 bd syringe 0.3ml 31g 6mm cannula broke off.The following information was provided by the initial reporter : the consumer reported that the needle breaks when inserting into the dog.Occurred date : unknown.Sample status : awaiting sample.

Event Description

It was reported that 1 bd syringe 0.3ml 31g 6mm cannula broke off.The following information was provided by the initial reporter : the consumer reported that the needle breaks when inserting into the dog.Occurred date : unknown.Sample status : awaiting sample.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 9/13/2021.H.6.Investigation: customer returned (10) 31gx6mm, 0.3ml insulin syringes in a sealed polybag from lot# 1095001.The consumer reported that needle breaks when inserting into dog, and also reported son went to re-shield needle and stuck himself after injection into dog.All 10 syringes were examined, then tested for point geometry, outer diameter and lube coverage.All observations fell within specification.No evidence of manufacturing defect was observed.Since no defects were observed, the alleged issue could not be confirmed.A review of the device history record was completed for batch# 1095001.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Root cause cannot be determined at this time as the issue is unconfirmed.

• Brand Name: SYRINGE 0.3ML 31G 6MM
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12411338
• MDR Text Key: 269629976
• Report Number: 1920898-2021-00951
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131138390
• UDI-Public: 00681131138390
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328521
• Device Lot Number: 1095001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1