BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER FLEX-TIP

    MDR report key: 24174883 · Received January 24, 2026

    Report

    Report Number
    3004748541-2026-00022
    Event Type
    Malfunction
    Date Received
    January 24, 2026
    Date of Event
    December 16, 2025
    Report Date
    May 5, 2026
    Manufacturer
    WELL LEAD MEDICAL CO., LTD.
    Product Code
    BTR
    UDI-DI
    10749065031655
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT PRODUCT WAS RETURNED TO THE SUPPLIER FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED PRODUCT. THE EVALUATION IDENTIFIED A HOLE IN THE CUFF, CONFIRMING THE REPORTED ISSUE. THE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION. A REVIEW OF COMPLAINT HISTORY IDENTIFIED THREE ADDITIONAL COMPLAINTS INVOLVING THE SAME PART NUMBER AND A SIMILAR FAILURE MODE WITHIN THE PRECEDING 24 MONTHS. NO ADDITIONAL TRENDS WERE IDENTIFIED AT THIS TIME; COMPLAINT DATA WILL CONTINUE TO BE MONITORED FOR ANY EMERGING TRENDS. THE DEVICE HISTORY RECORD FOR LOT 2506NC1616J WAS REVIEWED, AND CONFIRMED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 05 MAY 2026 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 (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

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 24 JAN 2026 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 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 AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2025, AFTER NASOTRACHEAL INTUBATION, A LEAK WAS IDENTIFIED THAT MAY HAVE CONTACTED THE NASAL BONE IMMEDIATELY POST-INTUBATION. THE NASAL TUBE WAS REMOVED AND REPLACED WITH A NEW TUBE. NO DELAY IN THERAPY, HARM, OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT. AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCED 2 DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS REFER TO 3004748541-2026-00023 FOR THE SECOND REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2025, AFTER NASOTRACHEAL INTUBATION, A LEAK WAS IDENTIFIED THAT MAY HAVE CONTACTED THE NASAL BONE IMMEDIATELY POST-INTUBATION. THE NASAL TUBE WAS REMOVED AND REPLACED WITH A NEW TUBE. NO DELAY IN THERAPY, HARM, OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT. AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCED 2 DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS REFER TO 3004748541-2026-00023 FOR THE SECOND REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2316 PARKER FLEX-TIP ENDOTRACHEAL TUBE, PREFORMED NASAL, HIGH VOLUME LOW PRESSURE, CUFFED (PFNC) BTR WELL LEAD MEDICAL CO., LTD. I-PFNC-65 (H-PFNC-65) 2506NC1616J 10749065031655

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown