BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPLIT, 14.5 FR ST 19CM STANDARD KIT

    MDR report key: 3921882 · Received May 28, 2014

    Report

    Report Number
    3006260740-2014-00265
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    BARD ACCESS SYSTEMS INC.
    Product Code
    MSD
    PMA / PMN Number
    K030020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVALUATION, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. 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

    ON (B)(6) 2014 IT WAS REPORTED THAT THE CUFF WAS DETACHED FROM THE CATHETER AND THE CATHETER WAS EXPOSED. THE DOCTOR HAD TO REMOVE THE CUFF AND CATHETER. THEN THE DOCTOR PLACED A NEW CATHETER FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314882 HEMOSPLIT, 14.5 FR ST 19CM STANDARD KIT MSD BARD ACCESS SYSTEMS INC. REXE1436

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention