BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LUMEN/PSI SET

    MDR report key: 2926586 · Received January 17, 2013

    Report

    Report Number
    1036844-2013-00017
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 16, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K002507
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE OPERATING ROOM AFTER SMOOTH INDUCTION AND SHEATH INSERTION IN THE PATIENT'S INTERNAL JUGULAR, IMMEDIATELY AFTER THE CATHETER WAS INSERTED AND FLOATING IN PLACE, A BLOOD LEAK WAS NOTED. THE LEAK WAS UNANTICIPATED AS THE INTRODUCTION WAS WITHOUT ISSUE AND WAS PLACED BY AN EXPERIENCED DOCTOR. DESPITE THE LEAK, THE CATHETER WAS NOT REPLACED BUT INSTEAD USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED DELAY, DEATH OR COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26268 MULTI-LUMEN/PSI SET CRITICAL CARE PSI PRODUCTS FOZ ARROW INTL., INC. RF2057713

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK