BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE CHANNEL FLAT DRAIN

    MDR report key: 20091353 · Received August 27, 2024

    Report

    Report Number
    MW5158931
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    August 6, 2024
    Report Date
    August 22, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    GBX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS MORNING WHEN BEDSIDE SHIFT REPORT WAS OCCURRING, I WAS NOTIFIED BY RN THAT THE DRAIN DURING THE NIGHT HAD STARTED TO MAKE A RINGING SOUND SO SHE PLACED A DRESSING AND TAPE OVER THE SITE AND IT HELPED TO STOP THE RINGING. THIS PATIENT RECEIVED AN ORDER TO DISCHARGE AND REMOVE THE DRAIN. THIS RN REMOVED THE DRESSING TO REMOVE THE DRAIN AND NOTICED THAT THE DRAIN HAD SNAPPED OFF COMPLETELY ABOVE THE SKIN AND THE SKIN WAS COMPLETELY CLOSED. THIS RN NOTIFIED THE NP WHO CAME TO THE BEDSIDE. THE PATIENT IS TO BE DISCHARGED AND HAVE THE DRAIN REMOVED AT THE SURGERY CENTER BY THE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493948 MEDLINE CHANNEL FLAT DRAIN CATHETER, IRRIGATION GBX MEDLINE INDUSTRIES, LP - NORTHFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown