BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW CATH RADIAL ARTERY

    MDR report key: 3111661 · Received May 8, 2013

    Report

    Report Number
    MW5030128
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    March 15, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE REPORTED WHEN SHE DISCONTINUED A RADIAL ARTERIAL LINE, THE SUTURE WAS CLIPPED WITH SCISSORS FROM A SUTURE REMOVAL KIT. WHEN THE LINE WAS PULLED OUT, SHE THOUGHT SHE MAY HAVE CUT IT AS A PORTION OF THE LINE WAS RETAINED IN THE BODY. UPON EXAMINATION OF THE SITE, THE EDGE APPEARED WITH A JAGGED EDGE LIKE IT WAS WORN VERSUS A STRAIGHT CUT. THE PHYSICIAN'S DISCHARGE DICTATION REFERENCES "THE LINE BROKE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202274 ARROW CATH RADIAL ARTERY ARTERIAL LINE DQO ARROW INTERNATIONAL, INC. RA-04020

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR