BEUDAMED
    FDA Adverse Event Injury Summary report: N

    19CM STRAIGHT HEMOSPLIT MI KIT WITH AIRGUARD

    MDR report key: 2903469 · Received January 3, 2013

    Report

    Report Number
    3006260740-2013-00008
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    September 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    MSD
    PMA / PMN Number
    K030020
    Adverse Event
    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 EVAL, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) OF REVG1020 SHOWED NINE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER (391593, 403561, 403565, 404134, 410159, 416306, 416307, 417748, 422176).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DR IMPLANTED A LONG-TERM CATHETER FROM RIGHT INTERNAL JUGULAR IN (B)(6) 2012. ON (B)(6) 2012, THE PT'S CATHETER WAS DISLODGED OUT OF HIS BODY WHEN HE WAS STAYING AT HOME. HE WENT TO THE HOSP AND THE DR FOUND THE CUFF STILL IN PT'S BODY. THE DR HAS TO IMPLANT A NEW CATHETER VIA LEFT IJ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3736 19CM STRAIGHT HEMOSPLIT MI KIT WITH AIRGUARD MSD C. R. BARD INC. (BASD) REVG1020

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention