BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM SELF-CATH NELATON CH12

    MDR report key: 1102024 · Received August 7, 2008

    Report

    Report Number
    2183558-2008-00010
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 10, 2008
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    GBM
    PMA / PMN Number
    K003873
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CATHETER WAS RECEIVED FOR EVALUATION WITHOUT PACKAGING. EXAMINATION OF THE CATHETER REVEALED WHAT APPEARED TO BE A CUTOFF. THE PACKAGING SUPERVISOR WAS NOTIFIED OF THE COMPLAINT, AND AFTER FURTHER EXAMINATION, CONFIRMED THAT THE CATHETER WAS OUT OF POSITION DURING THE PACKAGING PROCESS WHICH RESULTED IN THE CATHETER BEING CUT OFF. THE PACKAGING SUPERVISOR NOTIFIED PACKAGING PERSONNEL OF THIS COMPLAINT TO LESSEN THE CHANCE FOR RECURRENCE. NO OTHER COMPLAINT WERE NOTED WITH THIS LOT NUMBER.

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION RECEIVED, THE CATHETER WAS SHEARED OFF AT THE END, FROM THE FIRST EYE TO THE TIP AT A 60 DEGREE ANGLE. THE PIECE OF CATHETER WAS MISSING, AND THE PATIENT HAD AN ULTRASOUND SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM SELF-CATH NELATON CH12 INTERMITTENT CATHETER GBM COLOPLAST MANUFACTURING US, LLC 20-00412 5727183

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention