BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CWS 400 CLOSED WOUND SUCTION KIF

    MDR report key: 12459992 · Received September 10, 2021

    Report

    Report Number
    MW5103838
    Event Type
    Injury
    Date Received
    September 10, 2021
    Date of Event
    August 7, 2021
    Report Date
    September 8, 2021
    Manufacturer
    C. R. BARD, INC.
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING REMOVAL OF HEMOVAC DRAIN, THE DISTAL PORTION OF THE DRAIN BROKE OFF AND REMAINED IN THE WOUND REQUIRING SURGICAL INTERVENTION TO REMOVE THE RETAINED PORTION. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354799 CWS 400 CLOSED WOUND SUCTION KIF APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED GCY C. R. BARD, INC. 0043610 NGFR1042

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O