BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEX-GUIDE ENDOTRACHEAL TUBE INTRODUCER

    MDR report key: 21029666 · Received December 27, 2024

    Report

    Report Number
    3015966505-2024-00001
    Event Type
    Injury
    Date Received
    December 27, 2024
    Date of Event
    October 1, 2024
    Report Date
    December 24, 2024
    Manufacturer
    XPONENT HEALTHCARE INC.
    Product Code
    BSR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UF/IMPORTER REPORT #(B)(4). INCIDENT DATE: THE REPORTING FACILITY DID NOT SPECIFY A DATE WITHIN OCTOBER WHEN THE INCIDENT OCCURED. TO ERR ON THE SIDE OF CAUTION, THIS REPORT INDICATES THE INCIDENT DATE TO BE OCT-1-2024. REVIEW OF LOT HISTROY 111101 FOR THE TRACHEAL TUBE INDICATED THAT THE DEVICE WAS USED (9 YEAR) PAST THE EXPIRATION DATE OF THE PRODUCT. THE LOT WAS MANUFACTURED ON APRIL 10,2012 BY GREENFIELD MEDICAL SOURCING, INC. THE PRODUCT HAS A 3 YEAR EXPIRATION DATE. THE USE OF DEVICE PAST ITS EXPIRATION DATE MAY IMPACT ITS PERFORMANCE. XPONENT HEALTHCARE, INC. AQUIRED THE FLEX-GUIDE ENDOTRACHAEL TUBE INTRODUCER PRODUCT LINE FROM GREENFIELD MEDICAL SOURCING INC ON AUGUST 22, 2022. THE CUSTOMER PULLED ALL THE PRODUCTS FROM THEIR INVENTORY AND SHIPPED TO XPONENT HEALTHCARE. ALL LOTS WERE MANUFACTURED BY GREENFIELD MEDICAL SORUCING. ALL LOTS WERE DETERMINED TO BE PAST THEIR EXPIRATION DATE.

    Description of Event or Problem · 0

    PATIENT PRESENTED WITH DISLODGED TRACHEOSTOMY TUBE, STABLE AT TIME OF PRESENTATION. MD ATTEMPTING TO REINSERT NEW TRACHEOSTOMY TUBE 6.0 FR, AND BOUGIE TIP BROKE OFF INTO PATIENT AIRWAY WHEN ATTEMPTING TO REPLACE CURRENT TRACHEOSTOMY WITH NEW TRACH. FIRST AND A SECOND MD WERE PRESENT AT BEDSIDE AT TIME OF PROCEDURE. STORZ FIBER OPTIC SCOPE USED BY MD'S TO VISUALIZE AIRWAY. BOUGIE PLASTIC TUBE SHORTER, WITH CRACKED/JAGGED EDGE UPON INSPECTION. PATIENT MEDICATED WITH ETOMIDATE DURING TRACHEOSTOMY TUBE REPLACEMENT, BAG-VALVE-MASK (BVM) TO SUPPORT BREATHING/OXYGENATION UNTIL MEDICATION WORE OFF. PATIENT ALERT AFTER ETOMIDATE WORE OFF, AIRWAY PATENT, VITAL SIGNS STABLE ON ROOM AIR. REQUIRED TRANSFER TO ANOTHER HOSPITAL FOR RESOURCES NOT AVAILABLE AT CURRENT ED. SIGNIFICANT RESISTANCE MET WHEN USING MODERATE PRESSURE TO RE-INSERT TRACHEOSTOMY TUBE THAT HAD BECOME DISLODGED. INTRODUCER WAS INSERTED FIRST TIME AND ATTEMPT TO RE-INSERT TRACHEOSTOMY WAS MET WITH RESISTANCE. UPON THE SECOND ATTEMPT WITH THE INTRODUCER WAS WHEN THE INTRODUCER SNAPPED. ADDITIONAL INTRODUCERS WERE PULLED FROM STOCK AND FOUND TO ALSO SNAP/CRACK WITH MODERATE PRESSURE. ALL DEVICES WERE PULLED FROM HOSPITAL STOCK AND PATIENT AREAS. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? REPLACEMENT OF DISLODGED TRACHEOSTOMY TUBE WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730182 FLEX-GUIDE ENDOTRACHEAL TUBE INTRODUCER STYLET, TRACHAEL TUBE BSR XPONENT HEALTHCARE INC. GM85110 111101

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other