BEUDAMED
    FDA Adverse Event Other Summary report: N

    Q-SYTE LUER ACCESS SITE

    MDR report key: 1419343 · Received July 20, 2009

    Report

    Report Number
    9610847-2009-00043
    Event Type
    Other
    Date Received
    July 20, 2009
    Report Date
    June 22, 2009
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - RECEIVED ONE USED SAMPLE FOR THE INVESTIGATION. OUR QUALITY ENGINEER VISUALLY AND MICROSCOPICALLY INSPECTED THE RETURNED SAMPLE AND OBSERVED TOP SEPTUM DAMAGE AND AIR BUBBLES. THE DEVICE HISTORY COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. CONCLUSIONS - THE ENGINEER CONCLUDED THAT THE DAMAGE TO THE TOP SEPTUM MAY HAVE BEEN CAUSED BY ACTUATIONS GREATER THAN 100 AND/OR A SHARP MALE LUER INSERTED INTO THE BD Q-SYTE. A ROOT CAUSE COULD NOT BE DETERMINED SINCE THERE WAS NO INFORMATION ABOUT THE NUMBER OF ACTUATIONS PERFORMED AND TYPE OF MALE LUER USED BY THE CUSTOMER. THE INSTRUCTIONS FOR USE STATE: FOR PROPER USE, CLINICIANS MUST BE FAMILIAR WITH AND TRAINED IN THE USE OF THE BD Q-SYTE DEVICE. THE BD Q-SYTE DEVICE IS COMPATIBLE FOR USE ONLY WITH ISO LUER SLIP AND LUER LOCK CONNECTORS PROVIDED ON STANDARD IV ADMINISTRATION SETS, EXTENSION SETS, AND SYRINGES. FIRMLY AND COMPLETELY PUSH THE SYRINGE OR ADMINISTRATION SET INTO THE ACCESS PORT UNTIL SECURE CONNECTION HAS BEEN MADE. WHEN CONNECTING TO OR DISCONNECTING FROM THE BD Q-SYTE DEVICE, ALWAYS INSERT OR REMOVE THE MALE LUER USING A "STRAIGHT -ON/STRAIGHT-OFF APPROACH. ANGLED INSERTIONS/REMOVAL MAY CAUSE POOR FUNCTIONING AND/OR DAMAGE TO THE DEVICE. DO NOT EXCEED 100 ACTUATIONS OF THE DEVICE. (B)(4).

    Description of Event or Problem · 1

    WHILE WITHDRAWING ON THE PROXIMAL STOPCOCK OF THE CATHETER, THE NURSE DETECTED AIR BUBBLES. THE SEPTUM OF THE BD Q-SYTE WAS SLIGHTLY OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Q-SYTE LUER ACCESS SITE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other