BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRESSIVE MEDICAL OPERATIVE CHOLANGIOGRAM CATHETER

    MDR report key: 11738185 · Received April 28, 2021

    Report

    Report Number
    3009495876-2021-00001
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    April 2, 2021
    Report Date
    April 28, 2021
    Manufacturer
    BEILUN PLASTECH INC
    Product Code
    GBZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    THE NEEDLE AT THE END OF A CATHETER SEPARATED FROM THE PALSTIC CATHETER IN THE PATIENT'S GALLBLADDER DURING THE PROCEDURE AND WAS RETRIEVED. NO PATIENT HARM WAS DOCUMENTED AND NO EXTRA INTERVENTION WAS REQUIRED. NO DEVICE WAS AVAILABLE FOR RETURN. DEVICE INFORMATION WAS NOT DOCUMENTED BY THE USER FACILITY PRIOR TO DISPOSAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638649 PROGRESSIVE MEDICAL OPERATIVE CHOLANGIOGRAM CATHETER CHOLANGIOGRAM CATHETER GBZ BEILUN PLASTECH INC PMIORCA

    Patients

    Seq Age Sex Outcome Treatment
    1