BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXYGEN TUBING, KROT, 14' (S)

    MDR report key: 20871014 · Received December 6, 2024

    Report

    Report Number
    2028807-2024-00078
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    July 18, 2024
    Report Date
    April 8, 2025
    Manufacturer
    WESTMED LLC
    Product Code
    BYX
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6::TUBING. 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 DEC 2024 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 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 A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY. THE COMPLAINT INVOLVED A BENT OXYGEN TUBING, WHICH REPORTEDLY PREVENTED THE PATIENT FROM FEELING OXYGEN FLOW, RESULTING IN A SIGNIFICANT DROP IN OXYGEN SATURATION. THE PATIENT WAS HOSPITALIZED ONE WEEK AFTER THE DESATURATION EVENT. ACCORDING TO CUSTOMER FEEDBACK, THE PATIENT WAS AFFECTED. HOWEVER, NO PHOTOS, VIDEOS, OR PHYSICAL SAMPLES WERE PROVIDED FOR EVALUATION, SO THE ISSUE COULD NOT BE CONFIRMED. PER FEEDBACK FROM THE AIRLIFE PRINCIPAL PRODUCT MANAGER IN MARKETING, PART NUMBERS 0014 (DCR-14999) AND 0025 (DCR-12938) WERE DISCONTINUED EFFECTIVE JULY 16, 2024, DUE TO REDUNDANCY WITHIN THE PRODUCT PORTFOLIO. THESE SKUS ARE NO LONGER MANUFACTURED AND WERE OFFICIALLY DISCONTINUED UNDER THE REFERENCED DCRS. A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW WHICH DOES NOT REQUIRE REPORTING TO THE CAPA REVIEW BOARD. THIS IS THE FIRST COMPLAINT REPORTED FOR PART NUMBER 0014, "BENT/KINKED" FAILURE MODE. THERE WERE NO OTHER COMPLAINTS REPORTED FOR PART NUMBER 0014 DURING THE SAME TIMEFRAME. THIS IS THE FIRST COMPLAINT REPORTED FOR PART NUMBER 0025, "BENT/KINKED" FAILURE MODE. THERE WERE NO OTHER COMPLAINTS REPORTED FOR PART NUMBER 0025 DURING THE SAME TIMEFRAME. A RESOLUTION WAS SENT TO THE CUSTOMER. WE WILL CONTINUE TO MONITOR TRENDS DURING OUR PERIODIC COMPLAINT REVIEW MEETINGS.

    Additional Manufacturer Narrative · 0

    H6::TUBING 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 DEC 2024 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 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 A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY.

    Description of Event or Problem · 0

    AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT PRODUCTS, WHICH WERE ASSOCIATED WITH THE SAME ISSUES. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2028807-2024-00079 FOR THE SECOND REPORT. IT WAS REPORTED THAT "A BENT OXYGEN TUBING, THE PATIENT DID NOT FEEL THE OXYGEN COMING OUT AND HER SATURATION DROPPED VERY LOW. THE PATIENT WAS HOSPITALIZED A WEEK AFTER THIS DESATURATION".

    Description of Event or Problem · 0

    AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT PRODUCTS, WHICH WERE ASSOCIATED WITH THE SAME ISSUES. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2028807-2024-00079 FOR THE SECOND REPORT. IT WAS REPORTED THAT "A BENT OXYGEN TUBING, THE PATIENT DID NOT FEEL THE OXYGEN COMING OUT AND HER SATURATION DROPPED VERY LOW. THE PATIENT WAS HOSPITALIZED A WEEK AFTER THIS DESATURATION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2468194 OXYGEN TUBING, KROT, 14' (S) OXYGEN TUBING, KROT, 14' (S) BYX WESTMED LLC 0014 458460

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other