BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALTER O2 CANNULA

    MDR report key: 23721930 · Received December 4, 2025

    Report

    Report Number
    3004748541-2025-00134
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    October 29, 2025
    Report Date
    February 13, 2026
    Manufacturer
    SALTER LABS DE MEXICO DE S.A. DE C.V.
    Product Code
    BYX
    UDI-DI
    10889483570111
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B3. ADDITIONAL INFORMATION-INVESTIGATION COMPLETION: D4; H2; H6. THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION; HOWEVER, FUNCTIONAL TESTING WAS PERFORMED USING THE MANUFACTURER RETAINED 001350 TUBING, FROM A DIFFERENT LOT/BATCH ON A RESUSCITATION BAG PROVIDED BY THE REPORTER (NOT THE SUBJECT OF THE REPORTED EVENT). THE TEST RESULTS SHOWED THE TUBING PORT ON THE RESUSCITATION BAG WAS NOT INTERNATIONAL ORGANIZATION STANDARDIZATION (ISO) STANDARD; HOWEVER, THE TUBING WAS ABLE TO BE SEATED PROPERLY AND REMAINED ATTACHED DURING SIMULATED USE, INCLUDING WHEN THE TUBING WAS BEING PULLED. THE REPORTED ISSUE WAS NOT CONFIRMED DURING TESTING. THE MOST LIKELY ROOT CAUSE IS USER ERROR AS IF THE TUBING IS ONLY SEATED ON THE TAPERED SECTION OF THE RESUSCITATION BAG PORT IT WILL FALL OFF. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE DOCUMENTED UDI IS BASED ON THE STOCK/PRODUCT CODE PROVIDED BY THE REPORTER; THE UDI-PI IS NOT AVAILABLE AS NO LOT NUMBER WAS PROVIDED ALL INFORMATION REASONABLY KNOWN AS OF 13 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 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

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE DOCUMENTED UDI IS BASED ON THE STOCK/PRODUCT CODE PROVIDED BY THE REPORTER; THE UDI-PI IS NOT AVAILABLE AS NO LOT NUMBER WAS PROVIDED ALL INFORMATION REASONABLY KNOWN AS OF 04 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 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

    IT WAS REPORTED, WHILE PREPARING THE PATIENT FOR TRANSPORT TO THE INTENSIVE CARE UNIT (ICU), THE OXYGEN (O2) TUBING WAS CONNECTED TO THE SELF-INFLATING BAG (WHICH WAS BEING RAN ON AN OXYGEN TANK), AND THE PATIENT INSTANTLY DESATURATED TO THE LOW 80S. THE O2 SOURCE WAS SWITCHED TO THE ARIVO MACHINE; A TEMPORARY [UNSPECIFIED] HARM WAS NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED, WHILE PREPARING THE PATIENT FOR TRANSPORT TO THE INTENSIVE CARE UNIT (ICU), THE OXYGEN (O2) TUBING WAS CONNECTED TO THE SELF-INFLATING BAG (WHICH WAS BEING RAN ON AN OXYGEN TANK), AND THE PATIENT INSTANTLY DESATURATED TO THE LOW 80S. THE O2 SOURCE WAS SWITCHED TO THE ARIVO MACHINE; A TEMPORARY [UNSPECIFIED] HARM WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2422902 SALTER O2 CANNULA U/CONNECT-IT OXYGEN TUBING 7 FEET (2.1M) CRUSH RESISTANT OXYGEN TUBING, VYNIL BYX SALTER LABS DE MEXICO DE S.A. DE C.V. 001350 UNKNOWN 10889483570111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male