BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVISION-PLUS WITH NEUTRAL ADV.

    MDR report key: 4699268 · Received April 10, 2015

    Report

    Report Number
    MW5042094
    Event Type
    Malfunction
    Date Received
    April 10, 2015
    Date of Event
    March 14, 2015
    Report Date
    April 10, 2015
    Manufacturer
    RYMED TECHNOLOGIES, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    END CAP VALVE ON THE PTS IV BROKE APART WHICH HAD PROPOFOL INFUSION RUNNING INTO IT. WHEN THE VALVE BROKE, THE PT CAME OUT FROM UNDER SEDATION ABRUPTLY AND HAD A RUN OF SVT. ONCE THE PROBLEM WAS RECTIFIED, CARDIA RHYTHM RESUME TO NSR. THE NEUTRAL VALVES HAVE BEEN REPORTED BY FRONTLINE STAFF AS "FALLING APART," WE HAVE RECEIVED MORE THAN 5 INCIDENT REPORTS R/T THE NEUTRAL VALVES IN THE LAST MONTH. UNFORTUNATELY, WE HAVE NOT BEEN ABLE TO DETERMINE THE SPECIFIC LOT # SINCE THE PACKAGING HAD BEEN THROWN OUT PRIOR TO NOTING THE VALVE WAS DEFECTIVE. WE HAVE WORKED WITH THE (B)(4) TO PULL ALL THE OLD PRODUCT AND REPLACE THE NEW LOT NUMBERS. DATES OF USE: (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240843 INVISION-PLUS WITH NEUTRAL ADV. NEUTRAL VALVE FPA RYMED TECHNOLOGIES, INC. RYM-5001CL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other PICCLINE| PRIMARY TUBING| SECONDARY TUBING