BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE SUCTION SWAB SYSTEM

    MDR report key: 2476616 · Received February 29, 2012

    Report

    Report Number
    1419181-2012-00002
    Event Type
    Injury
    Date Received
    February 29, 2012
    Date of Event
    February 3, 2012
    Report Date
    February 6, 2012
    Manufacturer
    SAGE PRODUCTS, INC.
    Product Code
    JOL
    PMA / PMN Number
    K901806
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Description of Event or Problem · 1

    REPORT RECEIVED OF A USER ERROR RESULTING IN A SUCTION SWAB DISENGAGEMENT; LABELING INSTRUCTIONS REGARDING THE USE OF BITE BLOCK WERE NOT FOLLOWED. REPORTER STATED THAT ON (B)(6) 2012, A CERTIFIED NURSES ASSISTANT (CNA) ATTEMPTED TO PROVIDE ORAL CARE TO AN UNCOOPERATIVE RESIDENT. REPORTEDLY, RESIDENT BIT DOWN ON THE SUCTION SWAB AND THE PLASTIC STRAW SEPARATED INTO TWO PIECES. RESIDENT HAD CUFFED TRACHEOSTOMY AND WAS ON VENTILATOR. REPORTER STATED CNA, PHYSICIAN ASSISTANT, NURSES, AND (B)(6) ATTEMPTED TO RETRIEVE THE SWAB HEAD WITH ATTACHED PIECE OF PLASTIC FROM BACK OF RESIDENT'S MOUTH HOWEVER, ALL WERE UNSUCCESSFUL. PARAMEDICS NOTIFIED AND THEY TOO ATTEMPTED TO REMOVE IT WITHOUT SUCCESS. RESIDENT WAS TRANSFERRED TO (B)(6) HOSPITAL'S EMERGENCY ROOM (ER). REPORTEDLY, RESIDENT WAS "AGITATED, TACHYPNEIC AND DESATURATED." WHILE IN ER, RESIDENT WAS NOTED TO HAVE "STRIDOR" AND WAS GIVEN NIMBEX AND PROPOFOL TO TEMPORARILY PARALYZE HIM. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED WHICH SHOWED A FOREIGN BODY, "LIKELY SPONGE", NOTED AT THE LEVEL OF THE EPIGLOTTIS IN THE HYPOPHARYNX. REPORTEDLY, RESIDENT WAS RELEASED FROM ER AND ADMITTED TO A NURSING UNIT IN THE HOSPITAL. RIGHT AFTER ADMISSION TO UNIT, RESIDENT REPORTEDLY "COUGHED OUT THE PIECE OF SPONGE." FOLLOW-UP LARYNGOSCOPY ON (B)(6) 2012 SHOWED NO EVIDENCE OF FOREIGN BODY. 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." IT WAS REPORTED THAT ALTHOUGH THE RESIDENT WAS UNCOOPERATIVE, A BITE BLOCK WAS NOT USED AT THE TIME OF THE INCIDENT. REPORTEDLY, THE SUCTION SWAB WAS DISCARDED. LOT INFO WAS NOT AVAILABLE FROM REPORTER. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE USE SUCTION SWAB SYSTEM SUCTION SWAB JOL SAGE PRODUCTS, INC. 6512 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization SUCTION SOURCE| CUFFED-TRACHEOSTOMY TUBE| SUCTION TUBING| VENTILATOR