BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    P400 PREM U/M 16FR SIL COUDE

    MDR report key: 2844778 · Received November 1, 2012

    Report

    Report Number
    9612030-2012-00053
    Event Type
    Malfunction
    Date Received
    November 1, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 15, 2012
    Manufacturer
    COVIDIEN
    Product Code
    EZL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A FOLEY CATHETER. THE CUSTOMER REPORTS COUDE SILICONE FOLEY CATHETER WAS INSERTED. BLADDER PRESSURE MONITORING (BPM) WAS PERFORMED USING THE ADVISOR ADAPTOR. PATIENT PASSED AWAY A WEEK OR SO AFTER THE FOLEY WAS INSERTED. WHEN THE FOLEY WAS REMOVED FROM THE DECEASED PATIENT, THE TIP OF THE FOLEY WAS IN A TIGHT KNOT. THE CUSTOMER FURTHER REPORTS THAT THE BALLOON WAS IN USE AND THAT THERE WAS INITIAL OUTPUT OF URINE. CUSTOMER ADDITIONALLY ADDED THAT CAUSE OF DEATH WAS NOT RELATED TO THE FOLEY CATHETER AND THAT THE KNOT IN THE FOLEY CATHETER WAS IDENTIFIED AFTER THE PATIENT DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 P400 PREM U/M 16FR SIL COUDE FOLEY CATHETER EZL COVIDIEN P4P16CSD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN