BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDINAL HEALTH

    MDR report key: 918542 · Received August 21, 2007

    Report

    Report Number
    918542
    Event Type
    Injury
    Date Received
    August 21, 2007
    Date of Event
    September 14, 2007
    Report Date
    September 20, 2007
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KDQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THORACENTESIS CATHETER "CRUMBLED", "DISINTEGRATED" WHEN CATHETER WAS ADVANCED THROUGH THE TROCAR. FRAGMENTS OF CATHETER RETAINED IN PERITONEAL CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDINAL HEALTH THORACENTESIS CATHETER KDQ CARDINAL HEALTH 4341B L5C174

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization