BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2852627 · Received November 14, 2012

    Report

    Report Number
    1036844-2012-00328
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    November 11, 2012
    Report Date
    November 14, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DYB
    PMA / PMN Number
    K780532
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS BEING PERFORMED IN THE OPERATING ROOM. THE SHEATH WAS PLACED INTO THE PATIENT'S INTERNAL JUGULAR. WHILE FLOATING THE SWAN GANZ CATHETER, THE VALVE WAS LEAKING ON THE SHEATH. THEY WERE ABLE TO COMPLETE THE PROCEDURE EVEN WITH THE LEAKING ISSUE. THERE WAS A DELAY IN TREATMENT WITH NO PATIENT HARM AND NO PATIENT DEATH OR COMPLICATIONS WERE REPORTED.

    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 DYB ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK