BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURAPLEX

    MDR report key: 21213429 · Received January 22, 2025

    Report

    Report Number
    1314417-2025-00004
    Event Type
    Malfunction
    Date Received
    January 22, 2025
    Date of Event
    December 18, 2024
    Report Date
    March 19, 2025
    Manufacturer
    BOUND TREE MEDICAL, LLC
    Product Code
    CCK
    UDI-DI
    00810071631696
    PMA / PMN Number
    K063813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: 4756 (APPROPRIATE IMPACT TERM/CODE NOT AVAILABLE): ETCO2. 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 22 JAN 2025 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 OF "THE NASAL CANNULA CONNECTION TO THE REGULATOR BECAME DISCONNECTED FROM THE FLARE FITTING PORTION OF THE O2 REGULATOR WHILE IN USE" REGARDING PART 301-5707F-SE WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED BUT COULD POSSIBLY BE A RESULT OF A MISFIT TO O2 SOURCE. A RISK ASSESSMENT WAS PERFORMED AND THE ULTIMATE RISK WAS DETERMINED TO BE MEDIUM BUT DOES NOT REQUIRE THE INITIATION OF A CAPA. THERE HAVE BEEN 0 OTHER COMPLAINTS REGARDING THE SAME PART AND A SIMILAR ISSUE WITHIN THE 24 MONTHS PRECEDING THIS REPORTED EVENT. A RESOLUTION LETTER WAS SENT TO THE CUSTOMER. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR POSSIBLE TRENDS.

    Additional Manufacturer Narrative · 0

    H6: 4756 (APPROPRIATE IMPACT TERM/CODE NOT AVAILABLE): ETCO2. 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 22 JAN 2025 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

    THE NASAL CANNULA CONNECTION TO THE REGULATOR BECAME DISCONNECTED FROM THE FLARE FITTING PORTION OF THE O2 REGULATOR WHILE IN USE. IT WAS REPORTED FOR 3 DIFFERENT INCIDENTS FOR THE SAME DEVICE. THIS IS THE THIRD OF 3 REPORTS FOR THIS COMPLAINT. REFERENCE 1314417-2025-00002 FOR 1ST INCIDENT AND 1314417-2025-00003 FOR THE 2ND INCIDENT.

    Description of Event or Problem · 0

    THE NASAL CANNULA CONNECTION TO THE REGULATOR BECAME DISCONNECTED FROM THE FLARE FITTING PORTION OF THE O2 REGULATOR WHILE IN USE. IT WAS REPORTED FOR 3 DIFFERENT INCIDENTS FOR THE SAME DEVICE. THIS IS THE THIRD OF 3 REPORTS FOR THIS COMPLAINT. REFERENCE 1314417-2025-00002 FOR 1ST INCIDENT AND 1314417-2025-00003 FOR THE 2ND INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680821 CURAPLEX ADULT ORAL-NASAL 7FT ETCO2 FITS-ALL REFLECTIVE CONNECTOR,, CCK BOUND TREE MEDICAL, LLC 301-5707F-SE 240400075 00810071631696

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other