BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVER SOAKER 5 IN - 12.5 CM

    MDR report key: 2023571 · Received March 14, 2011

    Report

    Report Number
    MW5019823
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    March 6, 2011
    Report Date
    March 14, 2011
    Manufacturer
    1 FLOW CORPORATION
    Product Code
    BSO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MD ATTEMPTED TO REMOVE CATHETER. DIFFICULT TO REMOVE, MAY HAVE HEARD A POP. POSSIBLY SOME OF THE CATHETER HAD BEEN RETAINED AS THE BLACK TIP WAS NOT PRESENT ON THE CATHETER. LOCAL REPRESENTATIVE FOR ON-Q SYSTEM NOTIFIED. CT OF ABDOMEN AND PELVIS DONE, FRAGMENT OF CATHETER IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVER SOAKER 5 IN - 12.5 CM ON-Q BSO 1 FLOW CORPORATION 7A2718

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other