BEUDAMED
    FDA Adverse Event Death Summary report: N

    HUDSON ET TUBE HOLDER, STANDARD, W/BITE BLOCK

    MDR report key: 14356479 · Received May 11, 2022

    Report

    Report Number
    8040412-2022-00128
    Event Type
    Death
    Date Received
    May 11, 2022
    Date of Event
    April 29, 2022
    Report Date
    May 5, 2022
    Manufacturer
    TELEFLEX MEDICAL SDN. BHD.
    Product Code
    CBH
    UDI-DI
    14026704646972
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#: (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). MDR REPORT KEY (B)(4); MDR TEXT KEY (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT NO SAMPLE IS AVAILABLE FOR ANALYSIS. THE MANUFACTURING SITE REPORTS THAT "POWER CHOICE HAD CARRIED OUT THE STATIC TEST (SAMPLING CHECK) AS PER THE ASTM 2726 FOR EACH LOT THAT PRODUCED. THERE IS NO LOTS REJECTED IN-HOUSE DUE TO THE SAME ISSUE AS REPORTED BY COMPLAINANT." THE MANUFACTURING SITE ALSO REPORTS, "ACCORDING TO THE IFU AS IN PICTURE 1, THE USER ARE ADVISED TO AWARE OF THE PRECAUTIONS AND FOLLOW THE IFU ACCORDINGLY TO AVOID POTENTIAL INJURY TO THE PATIENTS." A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE 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

    IT WAS REPORTED VIA THE MEDWATCH FORM THAT THE ENDOTRACHEAL TUBE (ETT) HOLDER WAS IN PLACE, RT FOUND THE ETT TUBE MAY HAVE BEEN ALLOWED TO MIGRATE/DISLODGE. THERE ARE REPORTS THAT THIS TUBE HOLDER DOES NOT WORK AS DESIGNED TO SECURE THE ETT TUBES AND PREVENT FROM DISLODGING." THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION IS REPORTED AS "DECEASED": (B)(6) 2022. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS CONFIRMED THAT THE TELEFLEX ET HOLDER HAD BEEN IN PLACE ON (B)(6) 2022 PRIOR TO THE PASSING OF THE PATIENT AND WAS LEFT IN PLACE BY THE RT'S PRESENT POST CODE, AND DID NOT DIRECTLY CONTRIBUTE TO THE PATIENT'S DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA THE MEDWATCH FORM THAT THE ENDOTRACHEAL TUBE(ETT) HOLDER WAS IN PLACE, RT FOUND THE ETT TUBE MAY HAVE BEEN ALLOWED TO MIGRATE/DISLODGE. THERE ARE REPORTS THAT THIS TUBE HOLDER DOES NOT WORK AS DESIGNED TO SECURE THE ETT TUBES AND PREVENT FROM DISLODGING." THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION IS REPORTED AS "DECEASED"- (B)(6) 2022. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS CONFIRMED THAT THE TELEFLEX ET HOLDER HAD BEEN IN PLACE ON (B)(6) 2022 PRIOR TO THE PASSING OF THE PATIENT AND WAS LEFT IN PLACE BY THE RT'S PRESENT POST CODE, AND DID NOT DIRECTLY CONTRIBUTE TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1789635 HUDSON ET TUBE HOLDER, STANDARD, W/BITE BLOCK TRACHEAL TUBE FIXATION DEVICE CBH TELEFLEX MEDICAL SDN. BHD. IPN914325 KMZ21E0161 14026704646972

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Death| L| H| R N/A.| N/A.