BEUDAMED
    FDA Adverse Event Other Summary report: N

    @TRAY, TRACHEOSTOMY, BASIC, 4 GAU

    MDR report key: 1376628 · Received May 6, 2009

    Report

    Report Number
    1417592-2009-00030
    Event Type
    Other
    Date Received
    May 6, 2009
    Date of Event
    April 2, 2009
    Report Date
    May 1, 2009
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    LRQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE INCIDENT OCCURRED DURING TRACH CARE FOR A MALE RESIDENT. THE CLINICIAN REPORTED THAT A PIECE OF THE SWAB BROKE OFF IN THE INNER CANNULA. IT WAS UNKNOWN HOW MUCH PRESSURE WAS BEING APPLIED BY THE CLINICIAN. THE CUSTOMER HAD NO RESPIRATORY DISTRESS. THE TIP WAS REMOVED FROM THE INNER CANNULA WITHOUT FURTHER INCIDENT. IT DID NOT OCCLUDE THE AIRWAY. INSERTING THE COTTON TIP INTO THE OPENING OF THE TRACH/INNER CANNULA IS CONTRAINDICATED. THE LABELING ON THE TRACH CARE TRAY STATES: "CAUTION" ONLY USE COTTON TIP APPLICATORS FOR CLEANING AROUND TRACHEOSTOMY INCISION. DO NOT USE TO CLEAN LUMEN OF INDWELLING TUBE WHICH COULD BE DANGEROUS AND RESULT IN AIRWAY OBSTRUCTION."

    Description of Event or Problem · 1

    WHILE PROVIDING TRACH CARE TO ONE OF THEIR RESIDENTS, THE TIP OF THE PLASTIC SWAB BROKE OFF AND WENT INTO THE TRACH. THE TIP WAS REMOVED FROM INSIDE THE INNER CANNULA AND THE RESIDENT WAS REPORTED TO BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 @TRAY, TRACHEOSTOMY, BASIC, 4 GAU NONE LRQ MEDLINE INDUSTRIES, INC. DYND40582 08LA0035

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention