BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    27CM STRAIGHT HEMOSPLIT XK SURGEONS KIT WITH AIRGUARD

    MDR report key: 3102432 · Received May 1, 2013

    Report

    Report Number
    3006260740-2013-00191
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Report Date
    April 15, 2013
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    MSD
    PMA / PMN Number
    K033294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR AT THIS TIME FOR EVAL. A LOT HISTORY REVIEW (LHR) OF REVE1127 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    HEMOSPLIT PACKAGE WAS CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190687 27CM STRAIGHT HEMOSPLIT XK SURGEONS KIT WITH AIRGUARD MSD C.R. BARD, INC. (BASD) REVE1127

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention