BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO-VENT PLUS ARTERIAL BLOOD SAMPLING KIT

    MDR report key: 776553 · Received September 8, 2006

    Report

    Report Number
    1217052-2006-00069
    Event Type
    Malfunction
    Date Received
    September 8, 2006
    Date of Event
    June 15, 2006
    Report Date
    June 26, 2006
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    CBT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: SMITHS MEDICAL EVALUATION OF THE RETURNED EVENT SAMPLE - EXTENT OF REPORT: A SAMPLE WAS RETURNED FOR INVESTIGATION. THE LUER AREA OF THE SYRINGE WAS VIEWED UNDER 10X MAGNIFICATION AND NO MARKS OR DAMAGE OTHER THAN THE BROKEN LUER WAS DISCOVERED. THE CONDITION SEEN CAN OCCUR WHEN THE LUER IS MOVED SIDEWAYS IN A RAPID MOTION. IF THE LUER IS MOVED IN A SLOW MOTION, THE LUER WILL BEND WHICH RESULTS IN A WHITE LINE IN THE AREA OF THE BEND. A REVIEW OF THE IFU SHOWS THAT THE FILTER-PRO DEVICE SHOULD BE PUSHED ON TO THE LUER. STEP 4.A.1 STATES "FIRMLY PUSH FILTER-PRO DEVICE ONTO LUER AS ILLUSTRATED BELOW (FIG. 1)." THE PICTURE SHOWS THE FILTER-PRO DEVICE IS PUSHED STRAIGHT DOWN ONTO THE LUER. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMMENTS REGARDING THIS ISSUE WERE NOTED. THE MAINTENANCE LOG WAS REVIEWED AND NO COMMENTS REGARDING THE ISSUE WERE FOUND. CONCLUSION: BASED ON THE CONDITION OF THE SAMPLE, THE MOST LIKELY CAUSE IS RAPID SIDE MOTION OF THE FILTER PRO ON THE LUER.

    Description of Event or Problem · 1

    USER ALLEGES ONE EVENT OF WHEN ENGAGING THE FILTER PROTECTION, THE SYRINGE LUER BROKE INVOLVING BLOOD PROJECTIONS AT THE LEVEL OF THE FACE OF THE NURSE. NO TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO-VENT PLUS ARTERIAL BLOOD SAMPLING KIT TRAY, BLOOD COLLECTION CBT SMITHS MEDICAL ASD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO