BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 5385411 · Received January 22, 2016

    Report

    Report Number
    1710034-2016-00006
    Event Type
    Malfunction
    Date Received
    January 22, 2016
    Date of Event
    November 4, 2015
    Report Date
    January 20, 2016
    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
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 5191817. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. A SAMPLE IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USING A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER, A NURSE PUSHED THE SAFETY MECHANISM BUTTON TO RETRACT THE NEEDLE AND THE NEEDLE DID NOT RETRACT. THE NURSE WAS THEN KICKED BY THE PATIENT AND THE NURSE OBTAINED A NEEDLE STIK INJURY TO HIS/HER LEFT THUMB. IT IS UNKNOWN IF THE NURSE RECEIVED ANY MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44463 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5191817

    Patients

    Seq Age Sex Outcome Treatment
    1 Other