BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION 3724217 HOUSE IRRIGATOR 2X2.5FR

    MDR report key: 2991206 · Received March 6, 2013

    Report

    Report Number
    1045254-2013-00198
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 12, 2013
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    JZF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INSTRUMENTS NOT RETURNED FOR ANALYSIS, NO INVESTIGATIVE REPORT AVAILABLE. METHOD: NO TESTING METHODS PERFORMED. AS REPORTED: THE DAMAGE TO THE INSTRUMENTS WAS DISCOVERED POSTOPERATIVELY, THERE WAS NO PATIENT IMPACT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FACILITY RECEIVED THE INSTRUMENT SET FROM THE OR TO THE DECONTAMINATION ROOM. A TECH FOUND SCHUKNECHT SUCTION (B)(4) BROKEN IN PAN. INSTRUMENTS THEN HAND WASHED/IRRIGATED, SENT THROUGH WASHER. IN PREP AND PACK AREA, THE TECH PICKED UP HOUSE IRRIGATOR (B)(4) AND THE CONNECTION TIP FELL OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95023 SUCTION 3724217 HOUSE IRRIGATOR 2X2.5FR TUBE, EAR SUCTION JZF MEDTRONIC XOMED INC. 3724217 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 SUCTION (B)(4) SCHUKNECHT 24GA