BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX ENDOTRACHEAL TUBES SILICONIZED

    MDR report key: 17855487 · Received October 2, 2023

    Report

    Report Number
    3012307300-2023-09463
    Event Type
    Injury
    Date Received
    October 2, 2023
    Date of Event
    August 31, 2023
    Report Date
    October 2, 2023
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTR
    UDI-DI
    15019315018855
    PMA / PMN Number
    K790312
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: D4: LOT NUMBER, EXPIRATION DATE AND H4: DEVICE MANUFACTURE DATE IS UNKNOWN, AS NO VALID LOT NUMBER WAS PROVIDED. NO PRODUCT OR PHOTOS WERE RETURNED THEREFORE NO DEVICE ANALYSIS COULD BE COMPLETED. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN. IF THE PRODUCT IS RETURNED THE MANUFACTURER WILL RE-OPEN THE COMPLAINT FOR FURTHER DEVICE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE "BABY IN OHF MODE NO LONGER VIBRATES ACCORDING TO ITS POSITION". THE NURSE WAS FORCED TO HYPEREXTEND, WITH THE INTUBATION TUBE PULLED UPWARDS AND TO MODIFY ITS POSITION CONSTANTLY SO THAT THE CHILD COULD BE VENTILATED. THIS RESULTED IN AN INCREASE IN DEMAND DEPENDING ON THE CHILD'S POSITION. CLINICAL CONSEQUENCES AS DESATURATION, BRADYCARDIA, INCREASED OXYGEN REQUIREMENTS WERE REPORTED AND THE OUTCOME OF THE EVENT WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1846954 PORTEX ENDOTRACHEAL TUBES SILICONIZED TUBE, TRACHEAL (W/WO CONNECTOR) BTR SMITHS MEDICAL INTERNATIONAL, LTD. 15019315018855

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention