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

Model Number	328519
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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".
Additional 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
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11060721
• Report Number: 1920898-2020-01747
• Device Sequence Number: 14103806
• Product Code: FMF
• UDI-Device Identifier: 00681131138345
• UDI-Public: 00681131138345
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Model Number: 328519
• Device Catalogue Number: 328519
• Device Lot Number: 9336497
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1