BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO-VENT PLUS ARTERIAL BLOOD SAMPLING KIT (RAPIDLYTE)

    MDR report key: 1081857 · Received July 18, 2008

    Report

    Report Number
    1217052-2008-00095
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Report Date
    June 24, 2008
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - SMITHS MEDICAL ASD, INC. IS UNABLE TO FULLY EVALUATE THIS REPORT AS THE USER FACILITY DID NOT RETAIN THE SAMPLE INVOLVED. WITHOUT THE SAMPLE, THERE IS NO WAY TO DETERMINE IF THERE WAS AN INCOMPLETE FILTER OR MISSING FILTER IN THE UNIT. ANOTHER POSSIBILITY WOULD BE THE USER'S TECHNIQUE OF EXPELLING THE AIR FROM THE FILTER-PRO AIR BUBBLE REMOVAL DEVICE. A REVIEW OF THE MANUFACTURING RECORDS DOES NOT HAVE ANY REMARKS THAT WOULD HAVE AN IMPACT ON THIS REPORT. A REVIEW OF THE DEVICE INSTRUCTIONS FOR USE REVEALS THAT THERE IS A PRECAUTION THAT STATES "FAILURE TO ADVANCE PLUNGER SLOWLY MAY DISENGAGE FILTER-PRO RESULTING IN SPLASHING OF BLOOD." THERE IS ALSO A WORK STEP, A.4, THAT SATES "STOP PUSHING THE PLUNGER WHEN SAMPLE WETS THE FILTER. PRESSURE MAY RELEASE FILTER-PRO FROM THE SYRINGE." WITHOUT THE SAMPLE, WE ARE UNABLE TO DETERMINE IF THIS WAS DUE TO A PRODUCT MALFUNCTION OR USER ERROR.

    Description of Event or Problem · 1

    USER ALLEGES ONE EVENT OF AFTER PERFORMED A BLOOD DRAW THEY WERE USING THE FILTER PRO FOR AIR REMOVAL, THE FILTER PRO CAME OFF AND SPRAYED BLOOD IN EYES AND FACE OF TWO STAFF MEMBER. REPORTER STATES LIKELY FILTER PROTECTION CAP WAS OVER PRESSURIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO-VENT PLUS ARTERIAL BLOOD SAMPLING KIT (RAPIDLYTE) 75 JKA - BLOOD SAMPLING KIT, ARTERIAL JKA SMITHS MEDICAL ASD, INC. 1131528

    Patients

    Seq Age Sex Outcome Treatment
    1