BEUDAMED
    FDA Adverse Event Injury Summary report: N

    19 CM STRAIGHT HEMOSPLIT STANDARD KIT

    MDR report key: 2792327 · Received October 12, 2012

    Report

    Report Number
    3006260740-2012-00358
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 21, 2012
    Manufacturer
    C. R. BARD, INC. (BASD)
    Product Code
    MSD
    PMA / PMN Number
    K030020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THIS TIME FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE CATHETER WAS IMPLANTED INTO THE PATIENT¿S BODY ON (B)(6) 2012. WHEN THE USER REMOVED THE CATHETER OUT OF A PATIENT, HE FOUND THAT THE CUFF WAS DETACHED FROM THE CATHETER. THE CATHETER AND DETACHED CUFF WERE COMPLETED REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 19 CM STRAIGHT HEMOSPLIT STANDARD KIT MSD C. R. BARD, INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention