MAUDE Adverse Event Report: FACET TECHNOLOGIES CAREFINE; PEN NEEDLE

Catalog Number	1100027
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after injection using a 4mm x 32g carefine pen needle, the needle was broken and could not be located.User reported it may have fallen to the floor.No injury or medical intervention was reported.
Additional Manufacturer Narrative
Patient end of needle cannula was broken off at epoxy bond joint.Microscopic examination revealed that the cannula had broken due to a large shear force, as the lumen was greater than 50% occluded by the needle wall and there was some disruption to the epoxy bond adjacent to the cannula.

• Brand Name: CAREFINE
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): FACET TECHNOLOGIES; 3900 north commerce dr; atlanta GA 30344
• MDR Report Key: 7834145
• Report Number: 3011617315-2018-00001
• Device Sequence Number: 1445612
• Product Code: FMI
• UDI-Device Identifier: 00894743001789
• UDI-Public: 894743001789
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K140568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 1100027
• Device Lot Number: 5B606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 66