BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6308 2000ML DRAIN BG W SPOUT

    MDR report key: 13348775 · Received January 25, 2022

    Report

    Report Number
    9612030-2022-03143
    Event Type
    Malfunction
    Date Received
    January 25, 2022
    Date of Event
    January 24, 2022
    Report Date
    April 19, 2022
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KNX
    UDI-DI
    10884521002050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 0

    SINCE A LOT NUMBER WAS NOT PROVIDED, THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. ONE USED SAMPLE WITHOUT ITS ORIGINAL PACKAGING WAS RECEIVED FOR THE EVALUATION. A VISUAL INSPECTION OF THE RECEIVED SAMPLE WAS PERFORMED, IN ADDITIONAL A FUNCTIONAL TEST WAS CARRIED OUT. THE BAG WAS FILLED TO ITS MAXIMUM CAPACITY (2000 ML). THE INVESTIGATION WAS CARRIED OUT WITH THE MULTIFUNCTIONAL TEAM. UPON EVALUATION, THE REPORTED PROBLEM COULD NOT BE CONFIRMED. THE BAG WAS FILLED TO ITS MAXIMUM CAPACITY WITHOUT OBSERVING ANY CONDITION THAT PREVENTED ITS FILLING. ALL PROCESSES WERE REVIEWED. ALL PROCESSES AND CONTROLS WERE FOUND TO BE PROPERLY FOLLOWED, INCLUDING PACKAGING AND ALL INSPECTIONS PERFORMED ON THE PRODUCT. NO ABNORMAL CONDITIONS WERE FOUND THAT COULD TRIGGER THE REPORTED CONDITION. WE WILL KEEP MONITORING THE PROCESS FOR ANY ADVERSE TRENDS THAT REQUIRE IMMEDIATE ATTENTION. THIS COMPLAINT WILL BE USED FOR QA TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT CLOGGING OCCURRED AT THE ROUND PART WHERE THE TUBE AND BAG ARE CONNECTED. THERE WAS NO PATIENT HARM. THE DURATION OF USE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831374 6308 2000ML DRAIN BG W SPOUT COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER KNX CARDINAL HEALTH 6308 10884521002050

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown