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

Catalog Number	329424
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: 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 micro-fine¿ iv insulin syringe had a breach in the sterile barrier because a needle was bent and pierced the packaging.No serious injury, exposure of blood borne pathogens to mucous membrane, 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.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Unable to perform dhr due to unknown lot number.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.Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other, device single use?: no, device returned to manufacturer: no.
Event or Problem Description
It was reported that bd micro-fine¿ iv insulin syringe had a breach in the sterile barrier because a needle was bent and pierced the packaging.No serious injury, exposure of blood borne pathogens to mucous membrane, or medical intervention was reported.

• Brand Name: BD MICRO-FINE¿ IV INSULIN SYRINGE
• Common Device Name: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7781744
• Report Number: 1920898-2018-00635
• Device Sequence Number: 186525
• Product Code: FMF
• UDI-Device Identifier: 30382903294245
• UDI-Public: 30382903294245
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2018

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: Other
• Device Catalogue Number: 329424
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 09/05/2018
• 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