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

Catalog Number	329420
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7240669, medical device expiration date: 2022-10-31, device manufacture date: 2017-08-28.Medical device lot #: 7121840, medical device expiration date: 2022-05-31, device manufacture date: 2017-05-01.Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported with the use of the bd micro-fine¿ iv insulin syringe there was an issue with needles breaking during injection or when recapping.
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.There was one (1) batch of material# 8365002 (syringe 1.0ml asm bls 28g 1/2in sm700167) that went into finished batch# 7240669.There were zero (0) notifications noted that did not pertain to the complaint.A review of the device history record was completed for batch# 7121840.All inspections were performed per the applicable operations qc specifications.There were two (2) 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.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 with the use of the bd micro-fine¿ iv insulin syringe there was an issue with needles breaking during injection or when recapping.

• 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: 8126730
• Report Number: 1920898-2018-00907
• Device Sequence Number: 11134606
• Product Code: FMF
• UDI-Device Identifier: 30382903294207
• UDI-Public: 30382903294207
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2019

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: 329420
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 01/02/2019
• 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