BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN, PARKER ENDOTRACHEAL TUBE

    MDR report key: 21647147 · Received March 19, 2025

    Report

    Report Number
    3000219639-2025-00035
    Event Type
    Death
    Date Received
    March 19, 2025
    Date of Event
    February 17, 2025
    Report Date
    March 19, 2025
    Manufacturer
    PARKER MEDICAL
    Product Code
    BTR
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. WITHOUT A SAMPLE TO PERFORM FUNCTIONAL EVALUATION OR PHOTOGRAPHIC /VIDEO EVIDENCE THE ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 19 MAR 2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT- (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    THE PATIENT'S FATHER REPORTED, AN UNSPECIFIED AIR LIFE 'PRODUCT WITH A TUBE FAILED/BROKE; IT HAD A RARE BREAK [INTERNAL BREAK] IN IT AND IT CAUSED MY DAUGHTER TO END UP IN A VEGETATIVE STATE [BRAIN DAMAGED] WHERE I JUST LET HER GO. THE EVENT REPORTEDLY OCCURRED AT (B)(6) HOSPITAL; NO ADDITONAL INFORMATION WAS PROVIDED CONCERNING ANY OTHER PERFORMED MEDICAL INTERVENTION(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640745 UNKNOWN, PARKER ENDOTRACHEAL TUBE PARKER FLEX TIP, HV/LP POLYURETHANE CU BTR PARKER MEDICAL UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death