BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN

    MDR report key: 6816513 · Received August 24, 2017

    Report

    Report Number
    MW5071770
    Event Type
    Injury
    Date Received
    August 24, 2017
    Date of Event
    August 2, 2017
    Report Date
    August 9, 2017
    Manufacturer
    COVIDIEN LP
    Product Code
    KNZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CARDIOPULMONARY ARREST IMMEDIATELY FOLLOWING INSERTION REQUIRING INTUBATION AND MECHANICAL VENTILATION. ECHOCARDIOGRAM SHOWED AIR EMBOLUS. NEUROLOGICAL DEFICITS. UNABLE TO DETERMINE USER ERROR OR DEFECTIVE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599302 COVIDIEN PERMCATH KNZ COVIDIEN LP 8817748001 1621600102

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| S