BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVERSOAKER 5IN. (12.5CM)

    MDR report key: 2030585 · Received March 24, 2011

    Report

    Report Number
    MW5019915
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    March 6, 2011
    Report Date
    March 7, 2011
    Manufacturer
    I FLOW CORP.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    (B)(6) 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 REP FOR ON-Q SYSTEM NOTIFIED. CT ABDOMEN/PELVIS DONE FRAGMENT OF CATHETER IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERSOAKER 5IN. (12.5CM) ONQ MEB I FLOW CORP. 7A2718

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other