BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURAPLEX

    MDR report key: 23563137 · Received November 14, 2025

    Report

    Report Number
    1314417-2025-00096
    Event Type
    Injury
    Date Received
    November 14, 2025
    Date of Event
    October 15, 2025
    Report Date
    February 10, 2026
    Manufacturer
    BOUND TREE MEDICAL, LLC
    Product Code
    BTM
    UDI-DI
    00812277037029
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 14 NOV 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 "POP-OFF VALVE...HAD BECOME DISLODGED FROM THE BVM" REGARDING PART 2442-BVMPSA WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE THE PLASTICIZER LEACHES FROM THE ORANGE TETHERED REACTED WITH THE DICHLOROMETHANE GLUE, THE POP-OFF HOUSING, AND THE HYPERINFLATION ELBOW. THIS CHEMICAL REACTION LED TO THE RELEASE OF INTERNAL STRESS IN THE ELBOW/HOUSING, RESULTING IN THE FORMATION OF CRACKS OR EVEN FRACTURES. A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE MEDIUM BUT DOES NOT REQUIRE ESCALATION TO THE CAPA REVIEW BOARD. THERE HAVE BEEN 3 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. THE ULTIMATE RISK IS MEDIUM, AS THAT IS THE HIGHEST RISK OF THE PATIENT/CAREGIVER AND REGULATORY/COMPLIANCE CONSIDERATIONS: 1.PATIENT/CAREGIVER PERFORMED RISK ASSESSMENT WITH (B)(6) REVISION 2; THE MOST CLOSELY ASSOCIATED RISK IS ID (B)(4) (P1=1, P2=1) WITH A PROBABILITY OF HARM OCCURRING P=1 AND SEVERITY S=5 WHICH IS MEDIUM RISK. (B)(4). THEREFORE, THE PROBABILITY OF HARM OCCURRING (P) REMAINS THE SAME AS THE RMA AND IS DETERMINED TO BE MEDIUM RISK PER (B)(4) REV2. 2. REGULATORY/ COMPLIANCE REVIEWED (B)(4) REV2, AND THERE IS LOW REGULATORY/ COMPLIANCE RISK. 3. BRAND RECOGNITION AND CUSTOMER IMPACT REVIEWED (B)(4) REV2, AND THERE IS MEDIUM BRAND RECOGNITION/CUSTOMER IMPACT.

    Additional Manufacturer Narrative · 0

    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 14 NOV 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 (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

    IT WAS REPORTED THE DEVICE EXPERIENCED A MALFUNCTION THAT INHIBITED PROPER VENTILATION OF A PATIENT, SPECIFICALLY, THE POP-OFF VALVE COMPONENT, LOCATED BETWEEN THE BAG AND THE MANOMETER, BECAME DISLODGED FROM THE BAG VALVE MASK (BVM). THERE WAS NO REPORT OF DELAY IN THERAPY, HARM OR INJURY AS A RESULT OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DEVICE EXPERIENCED A MALFUNCTION THAT INHIBITED PROPER VENTILATION OF A PATIENT, SPECIFICALLY, THE POP-OFF VALVE COMPONENT, LOCATED BETWEEN THE BAG AND THE MANOMETER, BECAME DISLODGED FROM THE BAG VALVE MASK (BVM). THERE WAS NO REPORT OF DELAY IN THERAPY, HARM OR INJURY AS A RESULT OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2800159 CURAPLEX CURAPLEX SMALL ADULT/PEDIATRIC PREMIUM BVM W/ BAG RESERVOIR, MANOMETER, 25CM POP BTM BOUND TREE MEDICAL, LLC AF2000 UNKNOWN 00812277037029

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other