BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O2 CANNULA

    MDR report key: 24285345 · Received February 7, 2026

    Report

    Report Number
    3004748541-2026-00031
    Event Type
    Injury
    Date Received
    February 7, 2026
    Date of Event
    January 4, 2026
    Report Date
    March 25, 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 06 FEB 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.

    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 06 FEB 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. RISK ASSESSMENT: 1. PATIENT/CAREGIVER PERFORMED RISK ASSESSMENT WITH RMA-20017C , REVISION 10; THE MOST CLOSELY ASSOCIATED RISK IS ID R64 (P1=1, P2=1) WITH A PROBABILITY OF HARM OCCURRING P=1 AND SEVERITY S=4 WHICH IS MEDIUM RISK. THE CALCULATED P1 BASED ON COMPLAINTS AND SALES IN THE PREVIOUS 24 MONTHS IS (1/5). THEREFORE, THE PROBABILITY OF HARM OCCURRING (P) REMAINS THE SAME AS THE RMA AND IS DETERMINED TO BE MEDIUM RISK PER REF-20001-C1 REV2. 2.REGULATORY/ COMPLIANCE REVIEWED REF-20001-C1 REV2, AND THERE IS LOW REGULATORY/ COMPLIANCE RISK. 3. BRAND RECOGNITION AND CUSTOMER IMPACT REVIEWED REF-20001-C1 REV2, AND THERE IS MEDIUM BRAND RECOGNITION/CUSTOMER IMPACT. 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. COMPLAINT HISTORY REVIEW THE COMPLAINT HISTORY WAS REVIEWED IN GRAND AVENUE FROM REPORTED DATES (B)(6) 2024 THROUGH (B)(6) 2026, FOR PART NUMBER 001350 AND FAILURE MODE "A1202 - DECOUPLING, A1208 - FITTING PROBLEM, AND DISCONNECTION/CONNECTION ISSUE(S)". THERE WERE 30 OTHER COMPLAINT(S) REPORTED FOR THE SAME ISSUE AND PART NUMBER UNDER (B)(4) DURING THE SAME TIMEFRAME. SALES = (B)(4). CALCULATED OCCURRENCE (P1) = (B)(4). OCCURRENCE RANKING = 1/5.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT ON HOME BIPAP AND OXYGEN NEEDED TO BE TEE'D IN TO MACHINE. TUBING KEPT POPPING OFF CONNECTION, CONNECTION TAPED, STILL HAPPENING, PATIENT HOLDING ONTO CONNECTION".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT ON HOME BIPAP AND OXYGEN NEEDED TO BE TEE'D IN TO MACHINE. TUBING KEPT POPPING OFF CONNECTION, CONNECTION TAPED, STILL HAPPENING, PATIENT HOLDING ONTO CONNECTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164606 O2 CANNULA U/CONNECT-IT OXYGEN TUBING 7 FEET (2.1M) CRUSH RESISTANT OXYGEN TUBING, VYNIL TI BYX SALTER LABS 001350 UNKNOWN 10889483570111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other