BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUN MED

    MDR report key: 21998355 · Received May 9, 2025

    Report

    Report Number
    8030673-2025-00019
    Event Type
    Malfunction
    Date Received
    May 9, 2025
    Date of Event
    April 10, 2025
    Report Date
    May 9, 2025
    Manufacturer
    SUNMED HOLDINGS LLC
    Product Code
    BYX
    UDI-DI
    10889483570111
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 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. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 09 MAY 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 THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 8030673-2025-00020 FOR THE SECOND REPORT. REFER TO 8030673-2025-00021 FOR THE THIRD REPORT. IT WAS REPORTED, DUE TO KINKING IN THE TUBE THE PEDIATRIC PATIENT WAS NOT GETTING THE CORRECT FLOW OF OXYGEN WHILE IN USE WITH THE HIGH FLOW NASAL CANNULA. UNSUCCESSFUL ATTEMPTS WERE MADE TO ADJUST THE TUBING; HOWEVER, THE TUBE RETURNED TO THE BENT POSITION. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347471 SUN MED U/CONNECT-IT OXYGEN TUBING 7 FEET (2.1M) CRUSH RESISTANT OXYGEN TUBING, VYNIL BYX SUNMED HOLDINGS LLC 001350 UNKNOWN 10889483570111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown