BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONOPET OMNIULTRASONIC DISPOSABLE TUBING KIT

    MDR report key: 891766 · Received August 6, 2007

    Report

    Report Number
    MW5003359
    Event Type
    Other
    Date Received
    August 6, 2007
    Date of Event
    June 8, 2007
    Report Date
    August 6, 2007
    Manufacturer
    SYNRGETICS
    Product Code
    FPK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SONAPET MACHINE SET UP FOR CRANIOTOMY. TUBING FOR SONAPET APPEARED TO HAVE SLOW LEAD JUST PAST THE HUB WHERE 0.9% NACL BAG WAS SPIKED. USER BELIEVED THAT THERE WAS AN INTEGRITY ISSUE WITH THE STERILE TUBING AND MANUFACTURER WAS NOTIFIED. DIAGNOSIS: CARANITOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONOPET OMNIULTRASONIC DISPOSABLE TUBING KIT DISPOSABLE TUBING KIT FPK SYNRGETICS US062, 6110655

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other