BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMCATH

    MDR report key: 5529432 · Received March 28, 2016

    Report

    Report Number
    3004367028-2016-00002
    Event Type
    Malfunction
    Date Received
    March 28, 2016
    Date of Event
    February 28, 2016
    Report Date
    March 28, 2016
    Manufacturer
    GAMBRO DIALYSATOREN GMBH
    Product Code
    MPB
    PMA / PMN Number
    K100451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOT REPORTED LOT NUMBER. ONLY LIMITED INFORMATION WAS REPORTED. NO PATIENT RELATED DATA, NO SAMPLE OR PHOTO AND NO BATCH NUMBER WAS AVAILABLE.

    Description of Event or Problem · 1

    A PATIENT IN FRANCE HAD A GAM CATH 1325 VASCULAR ACCESS CATHETER INSERTED. TWO DAYS LATER, IT IS REPORTED THE CATHETER'S INTERNAL LUER WAS OBSTRUCTED AT THE LEVEL OF THE CLAMPS AND HAD TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185950 GAMCATH CATHETER, HEMODIALYSIS, NON-IMPLANTED MPB GAMBRO DIALYSATOREN GMBH GAMCATH GDHK-1325 (106661) NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention