BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NERVE BLOCK PAIN PACK

    MDR report key: 714323 · Received May 11, 2006

    Report

    Report Number
    2023988-2006-00014
    Event Type
    Malfunction
    Date Received
    May 11, 2006
    Report Date
    May 10, 2006
    Manufacturer
    INTEGRA NEUROSCIENCES
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT FOUR TRAYS OF ITEM NUMBER 3330 HAD LEAKAGE PROBLEMS WITH A 8 " MICROBORE EXTENSION TUBING # 6010160. THE REPORTED LEAKING OCCURRED ON THE NEEDLE END WHERE THE L/L CONNECTS TO THE TUBING. CUSTOMER ALREADY DISPOSED OF THE FOUR TRAYS. THE CUSTOMER HAS BEEN INSTRUCTED TO KEEP THE PRODUCT AND RETURN TO INTEGRA FOR PROPER EVALUATION SHOULD THE SITUATION RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NERVE BLOCK PAIN PACK KIT COMPONENTS CAZ INTEGRA NEUROSCIENCES * K001819

    Patients

    Seq Age Sex Outcome Treatment
    1 *