BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 6419024 · Received March 20, 2017

    Report

    Report Number
    1710034-2017-00064
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Date of Event
    March 2, 2017
    Report Date
    February 16, 2018
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS AVAILABLE FOR EVALUATION BUT HAS NOT BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    RESULTS: ONE USED SAMPLE IN AN OPEN PACKAGE WAS RETURNED FOR EVALUATION. A VISUAL/ MICROSCOPIC INSPECTION REVEALED THE NEEDLE WAS PARTIALLY RETRACTED INTO THE SAFETY BARREL LEAVING THE NEEDLE TIP EXPOSED. DAMAGE ON THE BOTTOM OF THE GRIP WHERE IT CONNECTS TO THE SAFETY BARREL CAUSING PARTIAL NEEDLE RETRACTION WAS ALSO OBSERVED. THE NEEDLE WAS PUSHED AND REPOSITIONED TO THE OUT POSITION AND A SIMULATED USE TEST WAS PERFORMED BY PRESSING THE SAFETY ACTIVATION BUTTON. THE RETRACTION WAS UNSUCCESSFUL AS THE DAMAGE TO THE GRIP INHIBITED FULL NEEDLE RETRACTION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6250884. CONCLUSION: THE ROOT CAUSE FOR THIS INCIDENT HAS BEEN DETERMINED TO BE A MANUFACTURING DEFICIENCY CAUSED BY DAMAGE TO THE GRIP. THE PLUG PROBE AND THE LOAD BARREL STATIONS IN ZONE 5 HAVE THE ABILITY TO BECOME MISALIGNED AND PRODUCE THE TYPE OF DAMAGE OBSERVED IN THE RETURNED SAMPLE. WHEN THERE IS A MISALIGNMENT, THE PROBE INADVERTENTLY CONTACTS THE EDGE OF THE GRIP AND CAUSES THE DAMAGE OBSERVED IN THE COMPLAINT SAMPLE. A CAPA HAS NOT BEEN INITIATED FOR THIS INCIDENT, BUT A QUALITY IMPROVEMENT PLAN IS UNDERWAY TO MINIMIZE DAMAGE TO THE GRIP AT THE PLUG LOAD STATION. THE GRIPPERS USED HAVE BEEN/WILL BE CHANGED TO GATHERING GRIPPERS WHICH SHOULD MINIMIZE THE CHANCE OF CHIPPING TO THE GRIPS FROM THE MACHINE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH AN INCORRECT DATE RECEIVED BY MANUFACTURER. THE CORRECT DATE RECEIVED BY MANUFACTURE WAS (B)(6) 2017.

    Description of Event or Problem · 1

    THE NEEDLE FAILED TO RETRACT ON THE SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201830 20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER SHIELDED IV CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6250884

    Patients

    Seq Age Sex Outcome Treatment
    1 Other