BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER

    MDR report key: 6965946 · Received October 20, 2017

    Report

    Report Number
    3009889060-2017-17006
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Date of Event
    August 30, 2017
    Report Date
    August 30, 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. THE BREAK HAPPENED AS THE DEVICE WAS BEING PUT ON A SYRINGE. WITH THE PIPE OF THE DEVICE UNREMOVED FROM THE PATIENT, THE OPERATORS OF THE DEVICE WERE ABLE TO REPLACE THE DAMAGED SECTION OF THE DEVICE USING TUBING FROM ANOTHER DEVICE OF THE SAME TYPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743653 LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER CHOLANGIOGRAPHY CATHETER GBZ BEILUN PLASTECH, INC PMIXL11 8170501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other