BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE FLAT FULL-FLUTED CHANNEL DRAIN

    MDR report key: 1934812 · Received December 3, 2010

    Report

    Report Number
    1934812
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    October 26, 2010
    Report Date
    December 3, 2010
    Manufacturer
    BARD
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS PULLING THE LEFT BREAST DRAIN. UPON REMOVING THE DRAIN, THE INTERNAL DRAIN PIECE SEPARATED FROM THE CLEAR EXTERNAL DRAIN TUBING. THE PATIENT WENT BACK TO THE OR FOR REMOVAL OF THE INTERNAL DRAIN PIECE, WHICH WAS REMOVED WITH NO COMPLICATIONS. NOTE: THE ORIGINAL PACKAGING WAS DISCARDED. WE ARE NOT 100% SURE, BUT IT APPPEARS THE LOT# SUBMITTED IS CORRECT, AS THE OR LOOKED THROUGH SEVERAL PACKAGES, AND THEY WERE ALL THE SAME LOT #.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE SURGEON STATED SHE WAS PULLING ON THE DRAIN IN ORDER TO REMOVE IT TO APPLY COMPRESSION. SHE FELT A "SNAP" RIGHT WHERE THE DRAIN IS FUSED TO THE TUBE. SHE SAYS SHE HAS BEEN DOING THIS FOR TEN YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE FLAT FULL-FLUTED CHANNEL DRAIN SILICONE FLAT DRAIN GCY BARD 072214 S101527

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR NO OTHER THERAPIES