BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER FLEX-TIP

    MDR report key: 23857842 · Received December 19, 2025

    Report

    Report Number
    3004748541-2025-00151
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    November 15, 2025
    Report Date
    March 4, 2026
    Manufacturer
    WELL LEAD MEDICAL CO., LTD.
    Product Code
    BTR
    UDI-DI
    10749065801807
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION; B5. THE COMPLAINT PRODUCT WAS RETURNED TO THE DISTRIBUTOR FOR EVALUATION, AND THE REPORTED EVENT WAS CONFIRMED. FUNCTIONAL TESTING OF THE RETURNED PRODUCT INFLATING TUBE DETACHED. THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF COMPLAINT HISTORY IDENTIFIED TWO ADDITIONAL COMPLAINT INVOLVING THE SAME PART AND A SIMILAR ISSUE WITHIN THE 24 MONTHS PRECEDING THIS REPORTED EVENT. NO ADDITIONAL TRENDS WERE IDENTIFIED AT THIS TIME. CONTINUED MONITORING WILL REMAIN IN PLACE TO DETECT ANY EMERGING TRENDS. THE DEVICE HISTORY RECORD FOR LOT 2410ST2950M WAS REVIEWED, AND CONFIRMED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 04 MAR 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 INFORMATION KNOWN 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 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, CAUSED, OR CONTRIBUTED TO A 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 19 DEC 2025 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 SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. 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 SUN MED 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 SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EIGHT DAYS AFTER INTUBATION, THE INFLATING TUBE DETACHED, REQUIRING REINTUBATION. THREE DAYS LATER, THE INFLATION TUBE OF THE SECOND DEVICE ALSO DETACHED. THERE WERE NO REPORTS OF THERAPY DELAY, HARM, OR INJURY RESULTING FROM THIS EVENT. AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS REFER TO 3004748541-2025-00150 FOR THE FIRST REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EIGHT DAYS AFTER INTUBATION, THE INFLATING TUBE DETACHED, REQUIRING REINTUBATION. THREE DAYS LATER, THE INFLATION TUBE OF THE SECOND DEVICE ALSO DETACHED. THERE WERE NO REPORTS OF THERAPY DELAY, HARM, OR INJURY RESULTING FROM THIS EVENT. SUNMED HOLDINGS LLC RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3004748541-2025-00150 FOR THE FIRST REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7597 PARKER FLEX-TIP PARKER FLEX-TIP TRACHEAL TUBE WITH STYLET, HIGH VOLUME LOW PRESSURE, CUFFED BTR WELL LEAD MEDICAL CO., LTD. I-PFST-80 (H-PFST-80) 2410ST2950M 10749065801807

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male