BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O2 CANNULA

    MDR report key: 25340965 · Received May 29, 2026

    Report

    Report Number
    3004748541-2026-00098
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 29, 2026
    Manufacturer
    SALTER LABS
    Product Code
    BYX
    UDI-DI
    10889483570111
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OFF 29 MAY 2026 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. 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 AIRLIFE. AIRLIFE 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 AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS (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 A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IT HAS BEEN NOTED THAT ON SEVERAL RESUSCITATION BAGGERS THAT THE OXYGEN TUBING IS KINKING OFF AND NOT PROVIDING OXYGEN TO THE BAGGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244197 O2 CANNULA U/CONNECT-IT OXYGEN TUBING 7 FEET (2.1M) CRUSH RESISTANT OXYGEN TUBING, VYNIL TI BYX SALTER LABS 001350 571981 10889483570111

    Patients

    Seq Age Sex Outcome Treatment
    1