BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 2992400 · Received March 1, 2013

    Report

    Report Number
    1036844-2013-00075
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 17, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    CAZ
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    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 THE PROCEDURE WAS PERFORMED IN THE ANESTHESIA DEPARTMENT. THE CATHETER WAS PLACED INTO THE MALE PATIENT'S NECK. DURING REMOVAL OF THE CATHETER BY THE PLASTIC SURGEON, THE STIMUCATH STEEL COIL BEGAN TO UNRAVEL. THE PLASTIC SURGEON PERFORMED A SURGICAL CUT DOWN AND WAS ABLE TO REMOVE THE UNRAVELED CATHETER INTACT. NOTHING WAS RETAINED IN THE PATIENT. THERE WAS NO DELAY IN TREATMENT AND NO PATIENT DEATH OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89116 NA ANESTHESIA PRODUCTS CAZ ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention