BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 G X 1.00 IN. (1.1 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 6548009 · Received May 5, 2017

    Report

    Report Number
    1710034-2017-00080
    Event Type
    Malfunction
    Date Received
    May 5, 2017
    Date of Event
    April 16, 2017
    Report Date
    May 4, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6092870. CONCLUSION: WITHOUT A SAMPLE, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PLACING A 20 G X 1.00 IN. (1.1 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER IN A PATIENT'S LEFT FOREARM, THE NURSE PRESSED THE SAFETY ACTIVATION BUTTON AND THE NEEDLE FAILED TO RETRACT. THE DEVICE WAS DISPOSED OF IN A SHARPS CONTAINER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328746 20 G X 1.00 IN. (1.1 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6092870

    Patients

    Seq Age Sex Outcome Treatment
    1 Other