BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARROW INTERNATIONAL, INC.

    MDR report key: 562952 · Received December 29, 2004

    Report

    Report Number
    562952
    Event Type
    Death
    Date Received
    December 29, 2004
    Date of Event
    December 15, 2004
    Report Date
    December 28, 2004
    Manufacturer
    ARROW
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT UNDER WENT INSERTION OF CANNON II PLUS IN (R) NECK. TAKEN TO ICU POST OP. PT WAS FOUND IN POOL OF BLOOD DURING ASSESSMENT. IT WAS FOUND THAT VENOUS PORT CLEARLY BROKEN OFF AT DEVICE. UNABLE TO CLAMP OFF TO CONTROL BLEEDING. PHYSICIAN REMVOED THE LINE. EBL DUE TO THE BROKEN LINE. MORE THAN 1 LITRE. VITALS -1545-82/71 P-99; 1640-BROKEN LINE DISCOVERED; RESUSCITION BEGUN; 1658-PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW INTERNATIONAL, INC. CANNON II PLUS 15FR X 9 1/2" MSD ARROW CS 15242 SP RF4099338

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death