BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER

    MDR report key: 6965924 · Received October 20, 2017

    Report

    Report Number
    3009889060-2017-17005
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Date of Event
    June 8, 2017
    Report Date
    September 15, 2017
    Manufacturer
    BEILUN PLASTECH, INC
    Product Code
    GBZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE TIP THAT CONNECTS THE TUBING TO THE FEMALE LUER FITTING BROKE OFF. SPECIFICALLY, THE FEMALE LUER FITTING BROKE AT THE BASE OF THE CONNECTION TO THE CATHETER TUBE. THIS RESULTED IN A DELAY IN THE PROCEDURE, SINCE THE DEVICE NEEDED TO BE REPLACED. NO INTERVENTION WAS REQUIRED TO PREVENT HARM TO THE PATIENT AS A RESULT OF THIS MALFUNCTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743667 LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER CHOLANGIOGRAPHY CATHETER GBZ BEILUN PLASTECH, INC PMIXL11 8160901

    Patients

    Seq Age Sex Outcome Treatment
    1 Other