MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ NEEDLE

Catalog Number 328468

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that the needle of a bd insulin syringe with the bd ultra-fine¿ needle broke off in the consumers stomach.The needle was removed without medical intervention.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: customer returned one 1/2cc, 8mm, 31g syringe in an open poly bag from lot # 7352846.Customer states that the needle broke off in her stomach and had bruising on injection site and the syringes were clogged.The returned syringe was examined and no broken cannula was observed.The sample was tested for point geometry, lube, and cannula od (specs: outer diameter for 31g: 0.0100¿-0.0105¿).The point exhibited proper geometry, the od was measured as 0.0102¿, and sufficient lube was observed.The sample was also tested and was able to draw and expel properly without any observed defects.A review of the device history record was completed for batch# 7352846.All inspections and challenges were performed per the applicable operations qc specifications.There were eight notifications noted that did not pertain to the complaint.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.

• Brand Name: BD ULTRA-FINE¿ NEEDLE
• Type of Device: NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7534761
• MDR Text Key: 109012954
• Report Number: 1920898-2018-00353
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908468039
• UDI-Public: 00382908468039
• 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: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328468
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 05/04/2018
• Supplement Dates FDA Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other