BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI KIT: 8.5 FR X 4-1/8 (10 CM)

    MDR report key: 1994262 · Received January 14, 2011

    Report

    Report Number
    1036844-2011-00008
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 23, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    KGZ
    PMA / PMN Number
    K781846
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHEATH WAS PLACED IN A MALE PT'S RIGHT INTERNAL JUGULAR. AT WHICH TIME, A (B)(4) CATHETER WAS PLACED THROUGH THE SHEATH. THE HEMOSTASIS VALVE WAS NOTICED TO BE LEAKING. CURRENTLY, PER THE DR'S ADVISEMENT, THE SHEATH REMAINS IN THE PT. THERE WAS NO DELAY IN TREATMENT AND NO PT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSI KIT: 8.5 FR X 4-1/8 (10 CM) CRITICAL CARE PSI PRODUCTS KGZ ARROW INTERNATIONAL INC RF0091803

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK