MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31G 6MM S/C U-100 RELION; PISTON SYRINGE

Model Number 328519

Device Problem Failure to Deliver (2338)

Patient Problem Pain (1994)

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that a syringe 1.0ml 31g 6mm s/c u-100 relion had insufficient cannula length during use.The following was reported by the initial reporter: "it was reported that the consumer feels the 6mm is too short for his thick skin and the needle hurts more than the 1/2" needles.Verbatim: consumer reported feels the 6mm is too short for his thick skin.Glucose values did not increase but feels they hurt more than the 1/2" needles when injecting.Takes 50 units of insulin".

Event Description

It was reported that a syringe 1.0ml 31g 6mm s/c u-100 relion had insufficient cannula length during use.The following was reported by the initial reporter: "it was reported that the consumer feels the 6mm is too short for his thick skin and the needle hurts more than the 1/2" needles.Verbatim: consumer reported feels the 6mm is too short for his thick skin.Glucose values did not increase but feels they hurt more than the 1/2" needles when injecting.Takes 50 units of insulin".

Manufacturer Narrative

Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch # 9336497.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.

• Brand Name: SYRINGE 1.0ML 31G 6MM S/C U-100 RELION
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11060721
• MDR Text Key: 231544622
• Report Number: 1920898-2020-01747
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131138345
• UDI-Public: 00681131138345
• 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: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328519
• Device Catalogue Number: 328519
• Device Lot Number: 9336497
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 04/07/2021
• Supplement Dates FDA Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1