BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAIN JACKSON PRATT 10X4

    MDR report key: 608096 · Received May 24, 2005

    Report

    Report Number
    1423507-2005-00072
    Event Type
    Malfunction
    Date Received
    May 24, 2005
    Date of Event
    April 22, 2005
    Report Date
    May 24, 2005
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GCY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    JP WOUND DRAIN BROKE UPON ATTEMPTED REMOVAL. A PORTION OF DRAIN REMAINS IN PATIENT. IT HAS NOT YET BEEN DETERMINED WHETHER IT WILL BE REMOVED AS PATIENT IS VERY ILL WITH CANCER. LOT NUMBER IS ONE OF THE THREE GIVEN (104-1433, 103-1118 OR 102-1539), BUT CUSTOMER ISN'T SURE WHICH.

    Description of Event or Problem · 1

    JP WOUND DRAIN BROKE UPON ATTEMPTED REMOVAL. A PORTION OF DRAIN REMAINS IN PT. IT HAS NOT YET BEEN DETERMINED WHETHER IT WILL BE REMOVED AS PT IS VERY ILL WITH CANCER. LOT NUMBER IS ONE OF THE THREE GIVEN, BUT CUSTOMER ISN'T SURE WHICH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAIN JACKSON PRATT 10X4 WOUND DRAIN GCY CARDINAL HEALTH SU130-1311 SEE B.5.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention