BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VNUS TUBING KIT X15

    MDR report key: 2469470 · Received February 20, 2012

    Report

    Report Number
    1282497-2012-00008
    Event Type
    Malfunction
    Date Received
    February 20, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 9, 2012
    Manufacturer
    KIMAL PLC
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(6) 2012. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH VNUS TUBING KIT X15. THE CUSTOMER STATES THAT 4 UNITS WERE USED AND 3 OF THEM BURST. THE PRESSURE WHEELS OF THE PUMP WERE SET TO THE MINIMUM. IT COULD NOT BEAR PRESSURE 60. THE SALINE SOLUTION DID NOT CONTAIN BICARBONATE OR LIDOCAINE. THE PT HAD BEEN INJECTED EPIDURAL ANESTHESIA. THE SURGICAL PROCEDURE WAS EXTENDED BECAUSE WHEN THE SET BURST IT SPLASHED THE FLOOR AND THE OPERATING ROOM CLEAN AREA. IT WAS DANGEROUS BECAUSE THE INFILTRATION PUMP WENT WET, THE FREQUENCY GENERATOR AND THE METALLIC TABLE IT WAS ON WERE BOTH SPLASHED TOO. THE EQUIPMENT WERE PLUGGED AND THIS COULD HAVE CAUSED AN ELECTRIC SHOCK FOR THE PERSONNEL MANIPULATING THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNUS TUBING KIT X15 VNUS TUBING KIT X15 KRA KIMAL PLC 10100/30409 11C0183

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK