BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNMED

    MDR report key: 20398209 · Received October 8, 2024

    Report

    Report Number
    1314417-2024-00028
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Date of Event
    September 10, 2024
    Report Date
    October 31, 2024
    Manufacturer
    SUNMED HOLDINGS LLC
    Product Code
    BTQ
    UDI-DI
    10889483042915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 08 OCT 2024 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 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 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 AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2024 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 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 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 AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. THE COMPLAINT REPORTED THAT THE UNIT "LENGTH WAS MUCH LONGER THAN THE PREVIOUS SUNMED PRODUCT LINE." AN INVESTIGATION WAS CONDUCTED, AND IT WAS DETERMINED THAT NO PATIENTS WERE AFFECTED. THE LENGTH OF THE NEW NASOS DID CHANGE BASED ON THE CUSTOMER CHANGE NOTIFICATION. THE NEW SILICONE NASO MOLDS RESULTED IN MINOR DIMENSIONAL CHANGES TO EACH SIZE OF ROBERTAZZI AIRWAY. DIMENSIONAL CHANGES ARE DETAILED IN TABLE 1 BELOW OF THE ATTACHED DOCUMENT. BASED ON PROJECT MANAGER-MARKETING, FEEDBACK THE CUSTOMER IS NOT LISTED ON THE SUPPLIER CHANGE. IF THE CUSTOMER PURCHASES THROUGH A DISTRIBUTOR, THE CUSTOMER SHOULD HAVE RECEIVED THE NOTIFICATION FROM THE DISTRIBUTOR (SEE ATTACHED EMAIL FEEDBACK/EXCEL ATTACHMENT IN EMAIL). 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 SECOND COMPLAINT REPORTED FOR PART NUMBER 1-5075-34 FOR "SIZE" FAILURE MODE. THERE WERE THREE COMPLAINTS REPORTED FOR PART NUMBER 1-5075-34 DURING THE SAME TIMEFRAME. THIS IS THE FIRST COMPLAINT REPORTED FOR PART NUMBER 1-5075-36 FOR "SIZE." THERE WERE NO OTHER COMPLAINTS REPORTED FOR PART NUMBER 1-5075-36 DURING THE SAME TIMEFRAME. WE WILL CONTINUE TO MONITOR TRENDS DURING OUR PERIODIC COMPLAINT REVIEW MEETINGS.

    Description of Event or Problem · 0

    LENGTH WAS MUCH LONGER THAN THE PREVIOUS SUNMED PRODUCT LINE. DISCOVERED UPON PT USE. "NO PTS WERE INJURED"

    Description of Event or Problem · 0

    LENGTH WAS MUCH LONGER THAN THE PREVIOUS SUNMED PRODUCT LINE. DISCOVERED UPON PT USE. "NO PTS WERE INJURED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729937 SUNMED LATEX FREE NASO A/W STER 34FR BTQ SUNMED HOLDINGS LLC 1-5075-34,1-5075-36 UNKNOWN 10889483042915

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other