BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUOUS NERVE BLOCK SET

    MDR report key: 2031329 · Received March 23, 2011

    Report

    Report Number
    1036844-2011-00104
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 22, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    CAZ
    PMA / PMN Number
    K021567
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION. FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANESTHESIOLOGY DEPARTMENT WAS PERFORMING THE PROCEDURE ON A FEMALE PATIENT FOR A FROZEN SHOULDER. THE CATHETER WAS PLACED IN THE PATIENT'S NECK. DURING REMOVAL, THE CATHETER COIL UNWOUND AND REMAINED TRUCK IN THE MUSCLE. AS A RESULT, THE CATHETER WAS SURGICALLY REMOVED FROM THE PATIENT. THIS CAUSED A DELAY IN TREATMENT WITH HARM TO THE PATIENT AND NO PATIENT DEATH. THE PATIENT WAS EVENTUALLY STABLE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011 FROM THE SALES REPRESENTATIVE CONFIRMED THIS CATHETER WAS USED SUCCESSFULLY FOR THE PATIENT AND THIS OCCURRED DURING REMOVAL. THIS WAS BEING REMOVED AT THE HOSPITAL WHEN THE ISSUE OCCURRED. WHEN THE CATHETER BEGAN TO UNRAVEL, THEY STOPPED THE REMOVAL PROCESS AND SURGICALLY REMOVED THE CATHETER. THE CATHETER WAS REMOVED ENTIRELY INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUOUS NERVE BLOCK SET ANESTHESIA PRODUCTS CAZ ARROW INTL., INC. RF0033480

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention