BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUOUS NERVE BLOCK KIT: 19 GA X 24 IN

    MDR report key: 2052036 · Received March 2, 2011

    Report

    Report Number
    2242445-2011-00029
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 1, 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
    CT, 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 BY CJCI DEPARTMENT THAT DURING INSERTION, THE PHYSICIAN EXPERIENCED DIFFICULTY DURING PLACEMENT. THE PHYSICIAN WAS REPOSITIONING THE CATHETER THROUGH THE INSERTION NEEDLE WHEN RESISTANCE WAS FELT. THEY PULLED OUT THE CATHETER AND FOUND THAT THE CATHETER WAS SHREDDED. AS A RESULT, ANOTHER CATHETER WAS PLACED SUCCESSFULLY FOR THE PT. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION REC'D ON (B)(6) 2011 STATED, THE CATHETER WAS FRAYED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK