BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 6281317 · Received January 26, 2017

    Report

    Report Number
    1710034-2017-00014
    Event Type
    Malfunction
    Date Received
    January 26, 2017
    Date of Event
    January 12, 2017
    Report Date
    January 26, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EIGHTEEN UNUSED REPRESENTATIVE SEALED SAMPLES WERE RETURNED FOR EVALUATION. A VISUAL/MICROSCOPIC INSPECTION REVEALED NO MECHANICAL/PHYSICAL DAMAGE TO ANY OF THE SPRINGS, NEEDLE HUBS, GRIPS, OR EVIDENCE OF ADHESIVE ON THE BUTTONS OR HUBS. A FUNCTIONAL USE TEST WAS PERFORMED BY DEPRESSION THE SAFETY ACTIVATION BUTTONS ON ALL SAMPLES AND ALL OF THE UNITS RETRACTED INTO THE SAFETY BARRELS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6230816. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    UDI #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE TEN SEPARATE INCIDENTS IN WHICH THE NEEDLE OF A 22 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER DID NOT RETRACT AFTER THE SAFETY ACTIVATION BUTTON WAS PRESSED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61510 22 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6230816

    Patients

    Seq Age Sex Outcome Treatment
    1 Other