BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O2 CANNULA

    MDR report key: 23846546 · Received December 18, 2025

    Report

    Report Number
    3004748541-2025-00143
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    November 9, 2025
    Report Date
    February 20, 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 OF 18 DEC 2025 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.

    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 OF 18 DEC 2025 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 21 CFR 803, 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. NO PHOTOS, VIDEOS, OR SAMPLES WERE PROVIDED FOR EVALUATION; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. HOWEVER, THE EVENT DESCRIBED IS A KNOWN FAILURE MODE AND IS UNDER REVIEW; WE WILL CONTINUE TO MONITOR FOR TRENDS DEVICE HISTORY RECORD (DHR) REVIEW: BASED ON THE DEVICE HISTORY RECORD (DHR) REVIEW THERE WERE NO ABNORMAL PROCESSING ISSUES NOTED. ALL PRODUCTS/PACKAGING WERE PRODUCED PER THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND INSPECTIONS. DATE OF MANUFACTURE: 18 FEB 2025. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY WAS REVIEWED IN GRAND AVENUE FROM REPORTED DATES ()(6) 2023 THROUGH (B)(6) 2025, FOR PART NUMBER 001350 AND FAILURE MODE "A1202 - DECOUPLING, A1208 - FITTING PROBLEM, AND DISCONNECTION/CONNECTION ISSUE(S)". THERE WAS/WERE 19 OTHER COMPLAINT(S) REPORTED FOR THE SAME ISSUE AND PART NUMBER UNDER (B)(4) DURING THE SAME TIMEFRAME. SALES = (B)(4) EA. CALCULATED OCCURRENCE (P1) = (B)(4). OCCURRENCE RANKING = 1/5.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLEAR U/CONNECT- IT O2 EXTENSION TUBING CAME APART FROM O2 TEE ON PATIENTS' HOME BIPAP CIRCUIT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLEAR U/CONNECT- IT O2 EXTENSION TUBING CAME APART FROM O2 TEE ON PATIENTS' HOME BIPAP CIRCUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257279 O2 CANNULA U/CONNECT-IT OXYGEN TUBING 7 FEET (2.1M) CRUSH RESISTANT OXYGEN TUBING, VYNIL TI BYX SALTER LABS 001350 537814 10889483570111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other