BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOOTHETTE ORAL CARE SUCTION SWAB

    MDR report key: 1266724 · Received November 21, 2008

    Report

    Report Number
    1419181-2008-00019
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    September 11, 2008
    Report Date
    October 27, 2008
    Manufacturer
    SAGE PRODUCTS, INC.
    Product Code
    KXF
    PMA / PMN Number
    k901806
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY CONTACT: RN, HOSPITAL -RISK MGMT. INSTRUCTIONS FOR USE STATE, "A BITE BLOCK SHOULD BE USED WHEN PERFORMING ORAL CARE ON PTS WITH ALTERED LEVELS OF CONSCIOUSNESS OR THOSE WHO CANNOT COMPREHEND COMMANDS." CONTACT STATED A BITE BLOCK WAS NOT USED AT THE TIME OF THE INCIDENT. CONTACT STATED THE INVOLVED SUCTION SWAB WAS SAVED; HOWEVER, DECLINED TO RETURN TO SAGE PRODUCTS, INC FOR EVAL. LOT INFO WAS NOT AVAILABLE FROM CONTACT. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.

    Description of Event or Problem · 1

    REPORT REC'D OF A USER ERROR RESULTING IN A SUCTION SWAB DISENGAGEMENT. RPTR STATED HER BROTHER (PT) WAS ADMITTED IN 2008, TO HOSP FOR A CRANIOPLASTY PROCEDURE. THE PT WAS TRANSFERRED TO REHAB FACILITY THE FOLLOWING DAY, AT 5:30 PM. AT APPROX 1:45 AM THE NEXT DAY, THE PT'S VITAL SIGNS BECAME UNSTABLE. AT APPROX 2:00 PM, A CODE BLUE WAS CALLED. SHORTLY AFTER THE CODE BLUE, THE PT WAS TRANSFERRED BACK TO HOSP. A DR PERFORMED A BRONCHOSOCPY PROCEDURE AND RETRIEVED A SWAB HEAD FROM THE PT'S LUNG. RPTR STATED THE SWAB HEAD WAS FROZEN AND SENT TO PATHOLOGY FOR EVAL. RPTR STATED THE PT SUBSEQUENTLY DEVELOPED PNEUMONIA. RPTR STATED THE INVOLVED SUCTION SWAB WAS A SAGE #6550, TOOTHETTE ORAL CARE SUCTION SWAB. LOT INFO WAS NOT AVAILABLE FROM RPTR. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE. FACILITY CONTACT STATED ON ORIGINAL DATE, THE PT WAS ADMITTED TO HOSP FOR A CRANIOPLASTY PROCEDURE. THE PT REC'D ORAL CARE WITH A #6550, TOOTHETTE SUCTION SWAB AND REPORTEDLY BIT DOWN THROUGH THE STICK OF THE SWAB. REPORTEDLY, X-RAYS WERE PERFORMED; HOWEVER, VISUALIZATION OF THE SWAB HEAD WAS NOT POSSIBLE. REPORTEDLY IT WAS ASSUMED THAT THE PT SWALLOWED THE SWAB HEAD. THE PT WAS TRANSFERRED TO REHAB FACILITY THE FOLLOWING DAY. CONTACT STATED THAT SOMETIME THE NEXT DAY, THE PT DEVELOPED OXYGEN DESATURATION ISSUES AND AMBU BAGGING VIA THE PT'S TRACHEOSTOMY TUBE WAS INITIATED. THE CONTACT SPECULATED THAT THE SWAB HEAD WAS ABOVE THE TRACHEOSTOMY TUBE CUFF AND WHEN THE TRACHEOSTOMY CUFF WAS MANIPULATED AT FACILITY, THE SWAB HEAD MIGRATED INTO THE PT'S LUNG. IT WAS REPORTED THAT THE PT WAS TRASNFERRED BACK TO HOSP THAT DAY AND A BRONCHOSCOPY WAS PERFORMED. CONTACT STATE THE PIECE OF FOAM WAS REMOVED FROM THE PT'S LUNG AND SENT FOR PATHOLOGY TESTING. THE PT RETURNED TO CENTER THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOOTHETTE ORAL CARE SUCTION SWAB SUCTION SWAB KXF SAGE PRODUCTS, INC. 6550 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| R TRACHEOSTOMY TUBE