BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT: TRACH CARE SET (CONTAINING SUSPECT Q-TIP)

    MDR report key: 3904206 · Received June 4, 2014

    Report

    Report Number
    1030451-2014-00004
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MEDICAL ACTION INDUSTRIES INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014, (B)(4) RECEIVED A COMPLAINT FROM OUR DISTRIBUTOR FOR (B)(4) CONVENIENCE KIT #25-715, ("TRACH CARE SET") FOR AN ISSUE WITH ONE OF ITS COMPONENTS" A COTTON-TIPPED APPLICATOR (#R1378) MANUFACTURED BY (B)(4). IMMEDIATELY OPENED COMPLAINT #(B)(4) FOR THIS ISSUE AND BEGAN AN INVESTIGATION. ON (B)(6)2014, A HOME HEALTH NURSE WAS USING THE COTTON-TIPPED APPLICATOR TO CLEAN THE AREA OF A TRACH TUBE OPENING WEN THE APPLICATOR BROKE IN TWO AND A PIECE OF IT WENT INSIDE THE TRACHEAL OPENING. THE HOME PATIENT WAS TRANSPORTED TO A HOSPITAL WHERE THE PIECE WAS SUCCESSFULLY REMOVED WITH NO ISSUED. THE ORIGINAL BROKEN APPLICATOR WAS DESTROYED SO (B)(4) COULD NOT EXAMINE IT; HOWEVER, THE NURSE SENT (B)(4) ONE BOX OF THE COMPLAINT LOT OF APPLICATORS TO EXAMINE. (B)(4) ALSO EXAMINED IN-HOUSE INVENTORY OF THE APPLICATOR, SAME LOT. THERE WAS NO REMAINING INVENTORY OF THE KIT LOT, BUT (B)(4) WAS ABLE TO EXAMINE A DIFFERENT LOT OF THE SAME STYLE KIT THAT CONTAINED THE SAME APPLICATOR LOT. THE INVESTIGATION SHOWED THAT IT WAS POSSIBLE TO BREAK SOME FEW - THOUGH NOT ALL - APPLICATORS BY INTENTIONALLY BENDING THE SHAFT; HOWEVER, THE APPLICATOR IS NOT LIKELY TO BREAK WHEN USED AS INTENDED FOR THE CLEANING PROCEDURE.

    Description of Event or Problem · 1

    A HOME HEALTH NURSE WAS USING A COTTON TIP APPLICATOR (NOT MANUFACTURED BY MEDICAL ACTION, BUT A COMPONENT IN A MEDICAL ACTION KIT) TO CLEAN THE AREA OF A PATIENT'S TRACHEOTOMY WHEN THE APPLICATOR BROKE IN TWO AND ONE PIECE OF THE APPLICATOR FELL INTO THE TRACHEA. THE PATIENT WAS TRANSPORTED TO HOSPITAL WHERE BROKEN APPLICATOR PIECE WAS SUCCESSFULLY REMOVED. NO EXTENDED CARE WAS NEEDED AND TO DATE NO ADDITIONAL ADVERSE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327241 KIT: TRACH CARE SET (CONTAINING SUSPECT Q-TIP) TRACH CARE KIT 25-715 BTO MEDICAL ACTION INDUSTRIES INC. 25-715 177858

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention