BEUDAMED
    FDA Adverse Event Injury Summary report: N

    24HR, ORAL SUCTION KIT, HP, 2HR.

    MDR report key: 7479530 · Received May 2, 2018

    Report

    Report Number
    1417592-2018-00034
    Event Type
    Injury
    Date Received
    May 2, 2018
    Date of Event
    March 23, 2018
    Report Date
    May 10, 2018
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    NXZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTING FACILITY RETURNED THE SAMPLE FOR EVALUATION AND THE CUSTOMER REPORTED ISSUE THAT THE GREEN FOAM DETACHED FROM THE SUCTION SWAB WAS CONFIRMED. THE SWAB STICK APPEARED TO HAVE A SMALL AMOUNT OF GLUE AT THE TIP WHERE THE GREEN FOAM WAS ATTACHED. THE ROOT CAUSE WAS RELATED TO A VENDOR PRODUCT ISSUE AND A SUPPLIER CORRECTIVE ACTION REPORT WAS OPENED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE REPORTING FACILITY WAS UNABLE TO FIND THE GREEN FOAM THAT DETACHED FROM THE ORAL SWAB AND FELL INTO PATIENT'S MOUTH. PER REPORT, THE PATIENT DID NOT HAVE TEETH AND DID NOT BITE DOWN WHILE THE ORAL CARE SWAB WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE REPORTING FACILITY AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. NO ADDITIONAL INFORMATION WAS PROVIDED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REPORTING FACILITY WAS UNABLE TO FIND THE GREEN FOAM THAT DETACHED FROM THE ORAL SWAB AND FELL INTO PATIENT'S MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322071 24HR, ORAL SUCTION KIT, HP, 2HR. NXZ MEDLINE INDUSTRIES INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other