BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FFB WH/BL CO-BR 0 T-2 1N 38" BIOMET

    MDR report key: 8084144 · Received November 19, 2018

    Report

    Report Number
    3004365956-2018-00336
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    June 8, 2018
    Report Date
    November 1, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAT
    PMA / PMN Number
    K063778
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER VISUAL INSPECTION OF THE PHOTOGRAPH RECEIVED, ONE SUTURE IS ON A (B)(6) BAG AS STATED BY THE CUSTOMER HOWEVER THERE IS NO EVIDENCE OF THE BOX SHRINK WRAP NOR THE REMAINING SUTURES, PER LABEL (B)(4) THE BOX SHOULD CONTAIN 12 SUTURES IN THE BOX AND NOT 10 AS REPORTED BY THE CUSTOMER. AS PART OF THE INVESTIGATION A PROCESS AUDIT TOOK PLACE AT THE (B)(6) AREA AND MANUFACTURING PROCESS, NO (B)(6) BAGS OF 2 1/2" WERE DETECTED AS SENT BY THE CUSTOMER IN THE SAMPLE PICTURE. NO ISSUES OR DISCREPANCIES WERE FOUND IN THE DEVICE HISTORY RECORD OF PRODUCT CODE 900267 / BATCH 74M1700694 THAT CAN BE RELATED TO THE FAILURE MODE REPORTED IN THE CUSTOMER COMPLAINT. PER EVIDENCE SENT IN THE COMPLAINT REPORT, A CORRECTIVE ACTION CANNOT BE IMPLEMENTED AT THE TIME SINCE THE QUANTITIES REPORTED (10 EA.) DOES NOT MATCH WITH THE QUANTITIES THAT THE BOX SHOULD HAVE ORIGINALLY (12 EA.) ALSO THERE IS NO EVIDENCE OF THE BOX SHRINK WRAP. IT IS CONCLUDED THAT THIS CONDITION WAS NOT CAUSED DURING THE MANUFACTURING PROCESS. ALSO, DURING THE PROCESS AUDIT NO 2 1/2" (B)(6) BAGS WERE FOUND; CURRENT (B)(6) BAGS SIZES ARE STANDARDIZED AS FOLLOWS: PART NUMBER: 109448, DIMENSIONS: 4" X 6"; 160679, 3" X 4"; 109449, 6" X 8"; 158219, 10" X 10"; 149129, 12" X 15". TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE CUSTOMER OPENED THE BOX THERE WERE 9 SUTURES STILL IN STERILE PACKED BUT THE 10TH SUTURE HAD BEEN OPENED AND PUT IT IN A (B)(6) BAG. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924145 FFB WH/BL CO-BR 0 T-2 1N 38" BIOMET SUTURE, NONABSORBABLE, SYNTHE GAT TELEFLEX MEDICAL 74M1700964

    Patients

    Seq Age Sex Outcome Treatment
    1