BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O2 CANNULA

    MDR report key: 23375159 · Received October 23, 2025

    Report

    Report Number
    3004748541-2025-00093
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    September 7, 2025
    Report Date
    January 9, 2026
    Manufacturer
    SALTER LABS DE MEXICO DE S.A. DE C.V.
    Product Code
    BYX
    UDI-DI
    10889483570111
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D9 ADDITIONAL INFORMATION-INVESTIGATION COMPLETION: D4; H2; H6. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION; HOWEVER, THE REPORTER PROVIDED A SAMPLE FROM A DIFFERENT LOT/BATCH. VISUAL EXAMINATION OF THE RETURNED SAMPLE DID NOT REVEAL ANY DEFORMATION ON EITHER CONNECTOR; THE COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD FOR LOT 552099 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE ROOT CAUSE IS NOT DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 09 JAN 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 IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 23 OCT 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.

    Description of Event or Problem · 0

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3004748541-2025-00094 FOR THE SECOND REPORT, REFER TO 3004748541-2025-00095 FOR THE THIRD REPORT. IT WAS REPORTED, THE U CONNECT-IT OXYGEN (O2) TUBING, USED ON A BABY GIRL ATTACHED TO THE 22 MM NIPPLE, WAS TOO LOOSE AND WOULD NOT STAY CONNECTED TO THE BUBBLE CONTINUOUS POSITIVE AIRWAY PRESSURE (BCPAP) SET-UP. AN ATTEMPT BY THE MEDICAL TEAM TO RESOLVE THE ISSUE BY REVERSING THE TUBING, WAS UNSUCCESSFUL. THE DEVICE WAS REPLACED FROM THE SAME LOT. THERE WAS NO REPORTED INJURY.

    Description of Event or Problem · 0

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3004748541-2025-00094 FOR THE SECOND REPORT. REFER TO 3004748541-2025-00095 FOR THE THIRD REPORT. IT WAS REPORTED, THE U CONNECT-IT OXYGEN (O2) TUBING, USED ON A BABY GIRL ATTACHED TO THE 22 MM NIPPLE, WAS TOO LOOSE AND WOULD NOT STAY CONNECTED TO THE BUBBLE CONTINUOUS POSITIVE AIRWAY PRESSURE (BCPAP) SET-UP. AN ATTEMPT BY THE MEDICAL TEAM TO RESOLVE THE ISSUE BY REVERSING THE TUBING, WAS UNSUCCESSFUL. THE DEVICE WAS REPLACED FROM THE SAME LOT. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834787 O2 CANNULA U/CONNECT-IT OXYGEN TUBING 7 FEET (2.1M) CRUSH RESISTANT OXYGEN TUBING BYX SALTER LABS DE MEXICO DE S.A. DE C.V. 001350 552099 10889483570111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown