BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUCTION SWAB KIT

    MDR report key: 3122588 · Received May 17, 2013

    Report

    Report Number
    1417592-2013-00041
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 16, 2013
    Report Date
    May 14, 2013
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    KXF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ORAL CARE WAS BEING PERFORMED ON A VENTILATOR DEPENDENT PT AND THE FOAM APPARENTLY CAME OFF THE SUCTION SWAB. THE ANESTHESIOLOGIST SEDATED THE PT AND REMOVED THE FOAM USING A LARYNGOSCOPE AND FORCEPS. THE FACILITY WAS NOT UTILIZING A BITE BLOCK DURING ORAL CARE. THE SAMPLE WAS RETURNED AND FORWARDED TO MFR FOR EVAL. THE SAMPLE SHOWED EVIDENCE OF GLUE ON THE SUCTION HANDLE WITH SMALL AMOUNTS OF THE FOAM STILL ATTACHED. THE DEVICE HISTORY RECORDS FOR THIS LOT WERE REVIEWED AND ALL FOAM PULL TESTS WERE WITHIN ESTABLISHED SPEC. WE HAVE TO TREND FOR THIS REPORTED ISSUE WITH THE FOAM. A ROOT CAUSE HAS NOT BEEN DETERMINED, BUT WE CANNOT RULE OUT THE POSSIBILITY THAT THE END USER BIT DOWN ON THE SUCTION SWAB AS IT WAS BEING REMOVED FROM THE MOUTH, CAUSING IT TO SHEAR OFF.

    Description of Event or Problem · 1

    DURING ORAL CARE, THE FOAM CAME OFF THE SWAB AND WAS REMOVED WITH A SCOPE AND FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218958 SUCTION SWAB KIT KXF MEDLINE INDUSTRIES, INC. 346-12-2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention