BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPLIT, 14.5 FR STNDRD KTI, 19CM, STRAIGHT

    MDR report key: 3874656 · Received April 24, 2014

    Report

    Report Number
    3006260740-2014-00198
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 21, 2014
    Report Date
    April 3, 2014
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    MSD
    PMA / PMN Number
    K030020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT HISTORY REVIEW (LHR) OF REVL0443 SHOWED FOUR OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (REVL0443) HAVE BEEN REPORTED FROM TWO (B)(6) FACILITIES. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, WHEN THE PATIENT CAME TO HOSPITAL TO DO THE HEMODIALYSIS. THE NURSE FOUND THAT THE INSERTION CATHETER WAS DETACHED. THE DOCTOR FOUND THE CUFF DETACHED FROM THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248306 HEMOSPLIT, 14.5 FR STNDRD KTI, 19CM, STRAIGHT MSD C.R. BARD, INC. (BASD) REVL0443

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR