BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE AUTOGARD

    MDR report key: 1407127 · Received June 19, 2009

    Report

    Report Number
    MW5011621
    Event Type
    Injury
    Date Received
    June 19, 2009
    Date of Event
    May 4, 2009
    Report Date
    June 19, 2009
    Manufacturer
    BECTON DICKENSON AND CO
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CATHETER TIP BROKE OFF DURING SAFETY NEEDLE RETRACTION UPON IV START - TIP LEFT IN VEIN TO BE RETRIEVED BY SURGERY - RETRIEVAL WAS UNSUCCESSFUL. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: SAFETY NEEDLE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD INSYTE AUTOGARD CATHETER FOZ BECTON DICKENSON AND CO BD INSYTE AUTOGARD 381444

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| S