BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE BILIARY CATHETER

    MDR report key: 6112425 · Received November 18, 2016

    Report

    Report Number
    6112425
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    February 17, 2016
    Report Date
    October 29, 2016
    Manufacturer
    BENTEC MEDICAL, INC.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A MIDDLE-AGED MALE PATIENT WAS UNDERGOING A BILE DUCT RECONSTRUCTION PROCEDURE AFTER SUSTAINING A BILE DUCT INJURY AT OUTSIDE FACILITY. THE BENTEC MEDICAL SILICONE BILIARY STENT WAS USED X 4 IN BILE DUCTS. WHILE SECURING FINAL PLACEMENT OF ONE OF THE STENTS, THE STENT SNAPPED INTO TWO PIECES. THE SURGEONS WERE ABLE TO RETRIEVE ENTIRE STENT IN 2 PIECES FROM INTRA HEPATIC DUCT, BUT WERE UNABLE TO ASCERTAIN WHICH OF THE SPECIFIC STENTS (OF THE 4 PLACED) HAD BROKEN WITH REGARDS TO LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763220 SILICONE BILIARY CATHETER CATHETER, BILIARY, DIAGNOSTIC FGE BENTEC MEDICAL, INC. GR83064-01 1105901

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR NO