BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUOUS NERVE BLOCK KIT

    MDR report key: 2171454 · Received June 30, 2011

    Report

    Report Number
    1036844-2011-00224
    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). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT, INSERTION FEMORAL BLOCK, OCCURRED WHILE IN THE HOSPITAL. AFTER THE CATHETER WAS INSERTED, THE PATIENT COMPLAINED OF PAIN AND FELT THE MEDICATION WAS NOT MOVING TOWARDS THE KNEE AND NOTICED LEAKING AT THE INSERTION SITE. AS A RESULT, THE CATHETER WAS REMOVED AND NOT REPLACED. AFTER INSPECTION OF THE DEVICE IT WAS OBSERVED THAT THE WIRE COIL WAS POKING THROUGH THE SIDE OF THE CATHETER AND NOT FROM THE TOP AS IT SHOULD. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WAS NO DELAY OR INTERRUPTION OF THERAPY NOTED. PATIENT COMPLICATIONS WERE REPORTED AS THE PATIENT DID NOT FEEL COMPLETE PAIN RELIEF. THERE WAS NO REPORT OF PATIENT DEATH OR INJURY. THE PATIENT OUTCOME 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