BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22G X 1.0" BD INSYTE¿ AUTOGUARD¿ WITH BLOOD CONTROL TECHNOLOGY

    MDR report key: 6270580 · Received January 23, 2017

    Report

    Report Number
    1710034-2017-00008
    Event Type
    Malfunction
    Date Received
    January 23, 2017
    Date of Event
    January 6, 2017
    Report Date
    February 8, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: A SAMPLE HAS BEEN RECEIVED FOR EVALUATION. A SUPPLEMENTAL MDR WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RESULT - A REVIEW OF DEVICE HISTORY RECORD FOR THE REPORTED LOT 6112806 REVEALED ALL REQUIRED CHALLENGE SAMPLES AND TESTING WAS CONDUCTED PER SPECIFICATIONS AND IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. THE REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT REPORTED. THE MANUFACTURING SITE RECEIVED ONE 22G BD IAG IV BLOOD CONTROL UNIT ACCOMPANIED BY AN OPEN PACKAGE FROM LOT 6112806. THE UNIT CONSISTED OF THE NEEDLE/HUB ASSEMBLY RETRACTED WITHIN THE SAFETY SHIELD (BARREL). THERE WERE TRACES OF DRIED MEDIA. A VISUAL/MICROSCOPIC EXAMINATION WAS PERFORMED. THE BUTTON WAS COMPLETELY DEPRESSED AND FULLY RETRACTED WITHIN THE BARREL WITH NO VISIBLE ANOMALIES. OBSERVATIONS FOR LEAKAGE OBSERVATIONS COULD NOT BE CONDUCTED IN RESPECT TO THIS NOTED FAILURE AS THE CATHETER/ADAPTER ASSEMBLY WAS NOT RETURNED FOR EVALUATION AND TESTING. A FUNCTIONAL (NEEDLE RETRACTION) TEST WAS PERFORMED. THE NEEDLE WAS PUSHED TO THE OUT POSITION AND RESET THE ACTIVATION BUTTON. NO ANOMALIES OR MECHANICAL/PHYSICAL DAMAGE WAS OBSERVED TO THE NEEDLE, SPRING, GRIP, NEEDLE/HUB OR EXCESSIVE GEL THAT WOULD CONTRIBUTE TO RETRACTION FAILURE. THE ACTIVATION BUTTON WAS DEPRESSED AND THE NEEDLE FULLY RETRACTED WITHIN THE BARREL DEMONSTRATING NO RESISTANCE. THE SPRING WAS REEVALUATED MICROSCOPICALLY AND NO ANOMALIES OR DAMAGE WAS OBSERVED. CONCLUSION - CONFIRMATION OF NEEDLE RETRACTION FAILURE WAS INCONCLUSIVE WITH THE RETURNED USED UNIT. THE BD ENGINEER CONFIRMED THERE WERE NO ANOMALIES OR DAMAGE TO THE UNIT OR COMPONENTS AND THE NEEDLE RETRACTED SUCCESSFULLY WHEN FUNCTIONALLY TESTED FOR RETRACTION. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WHEN THE SUSPECT DEVICE WAS BEING PLACED, BLOOD REFLUX LEAKED OUT FROM THE CATHETER. WHEN THE NEEDLE WAS THEN BEING REMOVED FOLLOWING PLACEMENT, THE NEEDLE FAILED TO RETRACT COMPLETELY INTO THE BARREL. THE USER MANUALLY RETRACTED THE NEEDLE WITHOUT ANY CLINICAL CONSEQUENCES TO EITHER THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54540 22G X 1.0" BD INSYTE¿ AUTOGUARD¿ WITH BLOOD CONTROL TECHNOLOGY INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6112806

    Patients

    Seq Age Sex Outcome Treatment
    1 Other