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

Catalog Number	329420
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2019
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.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 that during use of the bd micro-fine¿ iv insulin syringe that the needles break or "crooks" when injecting into the skin or when recapping the needle.
Event or Problem Description
It was reported that during use of the bd micro-fine¿ iv insulin syringe that the needles break or "crooks" when injecting into the skin or when recapping the needle.
Additional Manufacturer Narrative
Investigation: customer returned photos of a 1ml syringe.Customer states that the needles break or "crooks" when injecting into the skin or when recapping the needle.The attached photos were examined and no bent or broken cannula was observed.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.Bd was not able to duplicate or confirm the customer¿s indicated failure.

• Brand Name: BD MICRO-FINE IV INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8401471
• Report Number: 1920898-2019-00232
• Device Sequence Number: 13966575
• 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): 03/14/2019

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: Lay User/Patient
• Device Catalogue Number: 329420
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 03/14/2019
• 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