BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUDSON ET TUBE,CF,6.5

    MDR report key: 12738204 · Received November 2, 2021

    Report

    Report Number
    3003898360-2021-00988
    Event Type
    Injury
    Date Received
    November 2, 2021
    Date of Event
    September 3, 2021
    Report Date
    October 12, 2021
    Product Code
    BTR
    UDI-DI
    04026704396795
    PMA / PMN Number
    K822082
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. PART # 5-10113 REPORTED IS NOT BEING MANUFACTURED CURRENTLY, HOWEVER, ANOTHER PART NUMBER FROM THE SAME FAMILY (PART # 00001-17, LOT # 3141433) WAS USED FOR THE "VERIFICATION OF FAILURE MODE REPORTED IN THE CURRENT MANUFACTURING PROCESS" AND WAS CONDUCTED AS FOLLOWS: (B)(4) SAMPLES WERE TAKEN FROM THE CURRENT PRODUCTION; THE SAMPLES WERE VISUALLY INSPECTED AND ISSUE REPORTED "LEAK - DEVICE LEAK - CUFF" WAS NOT OBSERVED IN THE CURRENT MANUFACTURING PROCESS. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. 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 · 1

    IT WAS REPORTED THAT "INCIDENT HAPPENED ON (B)(6) 2021 IN THE ORTHOPEDIC-TRAUMA SURGERY UNIT. AFTER OROTRACHEAL INTUBATION OF THE PATIENT, THE CUFF HAD TO BE RE-INFLATED SEVERAL TIMES DUE TO REGULAR PRESSURE LEAKS. IT WAS MONITORED WITH A MANOMETER. THIS INCIDENT CAUSED AN INCREASE IN VENTILATORY VOLUMES AND OF THE FIO2. THE PATIENT DESATURATION DURING THIS PROCEDURE". IT WAS REPORTED THAT THE PATIENT HAD TO BE REINTUBATED. PATIENT CONDITION REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635651 HUDSON ET TUBE,CF,6.5 TUBE, TRACHEAL (W/WO CONNECTOR BTR IPN044729 UNKNOWN 04026704396795

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R