BEUDAMED
    FDA Adverse Event Injury Summary report: N

    19CM STRAIGHT HEMOSPLIT MI KIT WITH AIRGUARD

    MDR report key: 2994379 · Received March 5, 2013

    Report

    Report Number
    3006260740-2013-00105
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 18, 2013
    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 COMPLAINT OF A DETACHED SURECUFF AND HEAT SLEEVE IS CONFIRMED. GROSS AND MICROSCOPIC EXAMINATION CONFIRM A COMPLETE SEPARATION OF THE SURECUFF/HEAT SLEEVE FROM THE CATHETER. AT THIS TIME THE MECHANISM OF DAMAGE IS UNDETERMINED. THE DETACHED HEAT SLEEVE/SURECUFF WAS NOT RETURNED FOR EVAL. A LOT HISTORY REVIEW (LHR) OF REVG1020 SHOWED (B)(4).

    Description of Event or Problem · 1

    THE PT FOUND THE CATHETER OUT OF BODY WHEN HE WAS AT HOME. THE DOCTOR HAD TO RETRACT THE CATHETER. THE CUFF IS STILL IN PT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93110 19CM STRAIGHT HEMOSPLIT MI KIT WITH AIRGUARD MSD C. R. BARD INC. (BASD) REVG1020

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention