BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUOUS NERVE BLOCK KIT: 19 GA X 24IN

    MDR report key: 2501264 · Received March 16, 2012

    Report

    Report Number
    1036844-2012-00078
    Event Type
    Malfunction
    Date Received
    March 16, 2012
    Date of Event
    November 15, 2011
    Report Date
    March 14, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    CAZ
    PMA / PMN Number
    K021567
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE ANESTHESIOLOGIST WAS PLACING THE CATHETER THROUGH THE TUOHY NEEDLE DURING A NERVE BLOCK PROCEDURE. WHEN THE CATHETER WAS SLIGHTLY RETRACTED, HE FELT SOMETHING "CATCH". AT WHICH TIME, HE REMOVED BOTH THE NEEDLE AND CATHETER AS ONE AND NOTICED THE SHEATHING ON THE CATHETER HAD BEEN SHEARED. AS A RESULT, A NEW KIT WAS OPENED AND PLACED SUCCESSFULLY FOR THE PT. THERE WAS A DELAY IN TREATMENT WITH NO HARM TO THE PT, NO PT DEATH, AND NO PT COMPLICATIONS WERE REPORTED. THE PT OUTCOME WAS OKAY. ON (B)(6) 2012 - F/U INFO STATES THE CATHETER SHEATHING WAS CUT BUT DID NOT SHEAR OFF. NOTHING WAS RETAINED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUOUS NERVE BLOCK KIT: 19 GA X 24IN ANESTHESIA PRODUCTS CAZ ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK