BEUDAMED
    FDA Adverse Event Injury Summary report: N

    24HR, ORAL SUCTION KIT, CHG, HP, 4HR

    MDR report key: 7600710 · Received June 14, 2018

    Report

    Report Number
    1417592-2018-00059
    Event Type
    Injury
    Date Received
    June 14, 2018
    Date of Event
    April 13, 2018
    Report Date
    June 14, 2018
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    NXZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT REQUIRED LARYNGOSCOPY TO RETRIEVE GREEN FOAM THAT FELL FROM SUCTION SWAB WHILE PATIENT WAS RECEIVING ORAL CARE. PER REPORT, THE NURSE AND RESPIRATORY THERAPIST WHO WAS GIVING ORAL CARE TO THE PATIENT DID NOT ENCOUNTER ANY DIFFICULTIES WITH THE PATIENT SINCE THE PATIENT DID NOT BITE DOWN ON THE GREEN FOAM AT THE TIP OF THE SUCTION SWAB. IT WAS NOT IDENTIFIED WHETHER PATIENT WAS INTUBATED OR WHETHER AN ARTIFICIAL AIRWAY WAS IN PLACE AT THE TIME OF THE INCIDENT. IT WAS REPORTED THAT THE PATIENT REQUIRED LARYNGOSCOPY TO VISUALIZE AND SUCCESSFULLY RETRIEVE THE DETACHED GREEN FOAM FROM THE SUCTION SWAB. THE PATIENT IS REPORTEDLY DOING WELL AND IS STABLE AT THIS TIME. DUE TO THE REPORTED REQUIRED MEDICAL INTERVENTION, THIS MEDWATCH IS BEING FILED. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. A ROOT CAUSE COULD NOT BE IDENTIFIED AT THIS TIME. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT REQUIRED LARYNGOSCOPY TO RETRIEVE GREEN FOAM THAT FELL FROM SUCTION SWAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443911 24HR, ORAL SUCTION KIT, CHG, HP, 4HR NXZ MEDLINE INDUSTRIES INC. 18-043-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention