BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUOUS NERVE BLOCK KIT

    MDR report key: 2171440 · Received June 30, 2011

    Report

    Report Number
    1036844-2011-00225
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 30, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    CAZ
    PMA / PMN Number
    K021567
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED IN THE HOSPITAL. INSERTION SITE WAS A FEMORAL BLOCK. AFTER REMOVING THE CATHETER, IT WAS OBSERVED TO BE SHREDDED. AS A RESULT, THERE WAS NOT ANOTHER ATTEMPT AT THE PROCEDURE. NO MEDICAL/SURGICAL INTERVENTION WAS NEEDED. THERE WAS NO REPORT OF DELAY OR INTERRUPTION IN THERAPY. THERE WAS NO REPORT OF PATIENT DEATH OR INJURY. THE PATIENT OUTCOME IS THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUOUS NERVE BLOCK KIT ANESTHESIA PRODUCTS CAZ ARROW INTL., INC. RF1034033

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK