BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVER SOAKER

    MDR report key: 3001727 · Received March 8, 2013

    Report

    Report Number
    MW5029328
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 21, 2013
    Manufacturer
    I-FLOW CORP
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD UNDERGONE A REVISION OF A LEFT TOTAL KNEE ARTHROPLASTY, ON (B)(6). AFTER COMPLETION OF THE PROCEDURE, AN ON-Q PAIN PUMP WAS INSERTED TO FACILITATE PAIN CONTROL. ON (B)(6), THE PT WAS BEING PREPARED FOR DISCHARGE. A NURSE REMOVED THE ON-Q PAIN PUMP CATHETER NOTING THAT THE TIP OF THE TUBING WAS BLACK SIGNIFYING TO HER THAT THE CATHETER WAS INTACT AND COMPLETED REMOVED. ON (B)(6), A HOMECARE NURSE VISITING THE PT REMOVED THE DRESSING FROM THE PT'S KNEE AND FOUND A 3 INCH PIECE OF CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98697 SILVER SOAKER ON Q PAIN BALL MEB I-FLOW CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR