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

Catalog Number	329416
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd ultra-fine¿ insulin syringe had a broken needle while drawing medication, and leaked.No serious injury or medical intervention was reported.
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# 7241532.All inspections were performed per the applicable operations qc specifications.There were two (2) notifications (b)(4) noted for insufficient adhesive.There were five (5) notifications (b)(4)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 as no samples or photos were returned investigation conclusion: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.
Event or Problem Description
It was reported that bd ultra-fine¿ insulin syringe had a broken needle while drawing medication, and leaked.No serious injury or medical intervention was reported.

• Brand Name: BD ULTRA-FINE¿ INSULIN SYRINGE
• Common Device Name: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7855808
• Report Number: 1920898-2018-00691
• Device Sequence Number: 1964146
• Product Code: FMF
• UDI-Device Identifier: 00382903294169
• UDI-Public: 00382903294169
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2018

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 329416
• Device Lot Number: 7241532
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other