BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PMI

    MDR report key: 6553532 · Received May 9, 2017

    Report

    Report Number
    6553532
    Event Type
    Malfunction
    Date Received
    May 9, 2017
    Date of Event
    May 5, 2017
    Report Date
    May 8, 2017
    Manufacturer
    PROGRESSIVE MEDICAL, INC.
    Product Code
    GBZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LUER LOCK PORTION OF CATHETER BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336261 PMI CATHETER, CHOLANGIOGRAPHY GBZ PROGRESSIVE MEDICAL, INC. PMIXL11 008170101

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other