BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O2 CANNULA

    MDR report key: 23728591 · Received December 5, 2025

    Report

    Report Number
    3004748541-2025-00130
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    September 7, 2025
    Report Date
    February 25, 2026
    Manufacturer
    SALTER LABS
    Product Code
    BYX
    UDI-DI
    10889483570111
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 05 DEC 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 (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.

    Additional Manufacturer Narrative · 0

    CORRECTION: B5. THE COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION; HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED. TEN SAMPLES WERE PULLED FROM THE RETURNED MATERIAL AND TESTED FOR POP OFF PERFORMANCE AT 20 PSI AND 50 PSI USING A 22 MM ISO NIPPLE. ALL SAMPLES MET REQUIREMENTS, AND NO POP OFF WAS OBSERVED. THE INVESTIGATION CONCLUDED THAT THE MOST PROBABLE ROOT CAUSE WAS USER ERROR. A REVIEW OF COMPLAINT HISTORY IDENTIFIED 18 SIMILAR COMPLAINTS FOR THE SAME PART WITHIN THE PRECEDING 24 MONTHS. NO ADDITIONAL TRENDS WERE IDENTIFIED AT THIS TIME. CONTINUED MONITORING WILL REMAIN IN PLACE TO DETECT ANY EMERGING TRENDS. THE DEVICE HISTORY RECORD FOR LOT 552099 WAS REVIEWED, AND IT WAS CONFIRMED THAT THE PRODUCT WAS MANUFACTURED IN ACCORDANCE WITH APPLICABLE SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 25 FEB 2026 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 AIRLIFE REPRESENTS ALL OF THE INFORMATION KNOWN 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 PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE HOLDINGS COMPLAINT DATABASE AND 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 AN AIRLIFE PRODUCT WAS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE U CONNECT-IT OXYGEN TUBING WOULD NOT REMAIN ATTACHED TO THE BUBBLE CONTINUOUS POSITIVE AIRWAY PRESSURE (BCPAP) SETUP WITH THE 22 MM NIPPLE, AS BOTH THE SMALL AND WIDE ENDS OF THE TUBING WERE TOO LOOSE. TWO ADDITIONAL PRODUCT CODES WERE TRIED, WITH THE SAME RESULT. NO INFORMATION WAS PROVIDED REGARDING PATIENT IMPACT; HOWEVER, THERE WERE NO REPORTS OF THERAPY DELAY, HARM, OR INJURY RELATED TO THIS EVENT. SUNMED HOLDINGS LLC RECEIVED A SINGLE REPORT THAT REFERENCED MULTIPLE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS REFER TO 3004748541-2025-00129 FOR THE FIRST REPORT. REFER TO 3004748541-2025-00131 FOR THE THIRD REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE U CONNECT-IT OXYGEN TUBING WOULD NOT REMAIN ATTACHED TO THE BUBBLE CONTINUOUS POSITIVE AIRWAY PRESSURE (BCPAP) SETUP WITH THE 22 MM NIPPLE, AS BOTH THE SMALL AND WIDE ENDS OF THE TUBING WERE TOO LOOSE. TWO ADDITIONAL PRODUCT CODES WERE TRIED, WITH THE SAME RESULT. NO INFORMATION WAS PROVIDED REGARDING PATIENT IMPACT; HOWEVER, THERE WERE NO REPORTS OF THERAPY DELAY, HARM, OR INJURY RELATED TO THIS EVENT. AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCED MULTIPLE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS REFER TO 3004748541-2025-00129 FOR THE FIRST REPORT. REFER TO 3004748541-2025-00131 FOR THE THIRD REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2783915 O2 CANNULA U/CONNECT-IT OXYGEN TUBING 7 FEET (2.1M) CRUSH RESISTANT OXYGEN TUBING BYX SALTER LABS 001350 552099 10889483570111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown