BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22 G X 1 IN. (1.3 MM X 30 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 6281414 · Received January 26, 2017

    Report

    Report Number
    1710034-2017-00012
    Event Type
    Malfunction
    Date Received
    January 26, 2017
    Date of Event
    January 13, 2017
    Report Date
    February 9, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: ONE USED SAMPLE IN AN OPEN PACKAGE WAS RETURNED FOR EVALUATION. A VISUAL/MICROSCOPIC INSPECTION REVEALED THE UNIT CONSISTED OF THE NEEDLE/HUB ASSEMBLY RETRACTED WITHIN THE SAFETY SHIELD (BARREL) AND THE PROTECTIVE NEEDLE COVER IN PLACE. THERE WERE TRACES OF DRIED MEDIA, THE BUTTON WAS COMPLETELY DEPRESSED, AND THE NEEDLE WAS FULLY RETRACTED WITHIN THE (BARREL) WITH NO VISIBLE ANOMALIES OR DAMAGE. THE NEEDLE WAS PUSHED TO THE OUT POSITION AND THE ACTIVATION BUTTON WAS RESET. FURTHER VISUAL/MICROSCOPIC ANALYSIS OBSERVED NO ANOMALIES OR MECHANICAL/PHYSICAL DAMAGE WERE OBSERVED TO THE NEEDLE, SPRING, GRIP, NEEDLE/HUB OR EXCESSIVE GEL THAT WOULD CONTRIBUTE TO RETRACTION FAILURE. THE ACTIVATION BUTTON WAS PRESSED AND THE NEEDLE FULLY RETRACTED WITHIN THE BARREL DEMONSTRATING NO RESISTANCE. THERE WAS NO MICROSCOPIC EVIDENCE OF ANOMALIES OR DAMAGE OBSERVED IN THE RETRACTED CONDITION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES OR REJECT ACTIVITY DURING THE MANUFACTURE OF THE REPORTED LOT # 6112806. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HE NEEDLE OF A 22 G X 1 IN. (1.3 MM X 30 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER DID NOT RETRACT DURING USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61448 22 G X 1 IN. (1.3 MM X 30 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6112806

    Patients

    Seq Age Sex Outcome Treatment
    1 Other