BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACHEAL TUBE

    MDR report key: 14239995 · Received April 28, 2022

    Report

    Report Number
    8040412-2022-00101
    Event Type
    Injury
    Date Received
    April 28, 2022
    Date of Event
    March 31, 2021
    Report Date
    April 6, 2022
    Manufacturer
    TELEFLEX MEDICAL SDN. BHD.
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4).

    Additional Manufacturer Narrative · 0

    QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. THE MANUFACTURING SITE REPORTS THAT A SAMPLE WAS TAKEN FROM CURRENT PRODUCTION AND AN INFLATION TEST WAS PERFORMED AND NO DEFECTS WERE OBSERVED. THE PILOT BALLOON AND CUFF COULD BE INFLATED WITHOUT ANY ABNORMALITIES. WITHOUT THE ACTUAL DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    COMMUNICATION WAS RECEIVED FROM KPR KOLLNER & PARTNERS ATTORNEY REPORTING AN ALLEGED EVENT THAT TOOK PLACE AT (B)(6) ON (B)(6) 2021. THE PATIENT CONCERNED STATES THAT THEY HAD A FIBROMA OF THE LOWER LIP RESECTED UNDER INTUBATION ANESTHESIA AS AN AMBULANT PROCEDURE., SURGICAL DETAILS PROVIDED BY THE ATTORNEY AS PART OF THIS COMMUNICATION ALLEGES THAT AFTER PLACING THE TUBE, THE CUFF WAS INFLATED WITH A 10 ML SYRINGE BUT THE PILOT BALLOON COULD NOT BE INFLATED. ASSUMING THAT THE SYRINGE HAD NOT BEEN CORRECTLY ATTACHED, A NEW ATTEMPT WAS MADE TO INFLATE THE CUFF - AGAIN THE PILOT BALLOON DID NOT INFLATE WITH AIR. THE DECISION WAS MADE TO CHANGE THE TUBE. BEFORE THE TUBE WAS REMOVED, TWO ATTEMPTS WERE MADE TO REMOVE ANY AIR IN THE CUFF WITH THE SYRINGE. THE PILOT BALLOON WAS FLAT ALL THE TIME, WHICH MADE IT DIFFICULT TO REMOVE AIR BY USING THE SYRINGE. THE PILOT BALLOON WAS THEREFORE TORN OFF BEFORE EXTUBATION BUT THE CUFF WAS STILL FOUND SLIGHTLY FILLED WITH AIR AFTER THE TUBE WAS REMOVED. AFTER DISCHARGE THE CLIENT NOTICED AN INCREASING SWELLING IN THE NECK AREA, SHE ATTENDED THE EMERGENCY ROOM OF THE MUNICH CLINIC HARLACHING AND WAS SUBSEQUENTLY HOSPITALIZED IN THE CLINIC FOR INTERNAL INTENSIVE CARE MEDICINE. A CT SCAN OF THE THORAX AND NECK AND AN EMERGENCY BRONCHOSCOPY REVEALED A LONGITUDINAL TEAR OF THE POSTERIOR TRACHEAL WALL OF ABOUT 4 CM IN LENGTH WITH PRONOUNCED MEDIASTINAL AND SOFT TISSUE EMPHYSEMA.

    Description of Event or Problem · 0

    COMMUNICATION WAS RECEIVED FROM KPR KOLLNER & PARTNERS ATTORNEY REPORTING AN ALLEGED EVENT THAT TOOK PLACE AT (B)(6) ON (B)(6) 2021. THE PATIENT CONCERNED STATES THAT THEY HAD A FIBROMA OF THE LOWER LIP RESECTED UNDER INTUBATION ANESTHESIA AS AN AMBULANT PROCEDURE., SURGICAL DETAILS PROVIDED BY THE ATTORNEY AS PART OF THIS COMMUNICATION ALLEGES THAT AFTER PLACING THE TUBE, THE CUFF WAS INFLATED WITH A 10 ML SYRINGE BUT THE PILOT BALLOON COULD NOT BE INFLATED. ASSUMING THAT THE SYRINGE HAD NOT BEEN CORRECTLY ATTACHED, A NEW ATTEMPT WAS MADE TO INFLATE THE CUFF - AGAIN THE PILOT BALLOON DID NOT INFLATE WITH AIR. THE DECISION WAS MADE TO CHANGE THE TUBE. BEFORE THE TUBE WAS REMOVED, TWO ATTEMPTS WERE MADE TO REMOVE ANY AIR IN THE CUFF WITH THE SYRINGE. THE PILOT BALLOON WAS FLAT ALL THE TIME, WHICH MADE IT DIFFICULT TO REMOVE AIR BY USING THE SYRINGE. THE PILOT BALLOON WAS THEREFORE TORN OFF BEFORE EXTUBATION BUT THE CUFF WAS STILL FOUND SLIGHTLY FILLED WITH AIR AFTER THE TUBE WAS REMOVED. AFTER DISCHARGE THE CLIENT NOTICED AN INCREASING SWELLING IN THE NECK AREA, SHE ATTENDED THE EMERGENCY ROOM OF THE (B)(6) AND WAS SUBSEQUENTLY HOSPITALIZED IN THE CLINIC FOR INTERNAL INTENSIVE CARE MEDICINE. A CT SCAN OF THE THORAX AND NECK AND AN EMERGENCY BRONCHOSCOPY REVEALED A LONGITUDINAL TEAR OF THE POSTERIOR TRACHEAL WALL OF ABOUT 4 CM IN LENGTH WITH PRONOUNCED MEDIASTINAL AND SOFT TISSUE EMPHYSEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59608 ENDOTRACHEAL TUBE ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL SDN. BHD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L| H NONE REPORTED.| NONE REPORTED.