BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER FLEX-TIP

    MDR report key: 24173625 · Received January 24, 2026

    Report

    Report Number
    3004748541-2026-00019
    Event Type
    Malfunction
    Date Received
    January 24, 2026
    Date of Event
    December 25, 2025
    Report Date
    May 5, 2026
    Manufacturer
    WELL LEAD MEDICAL CO., LTD.
    Product Code
    BTR
    UDI-DI
    10749065801753
    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 PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION. THE CUSTOMER REPORTED TWO POSSIBLE LOT NUMBERS (2501ST0098L AND 2505ST1325L) FOR THE EVENT, AS THEY WERE UNABLE TO DETERMINE WHICH LOT NUMBER CORRESPONDED TO EACH REPORTED OCCURRENCE, HOWVER A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS FOR TEH REPORTED LOT NUMBERS. 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 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 SEVERAL HOURS AFTER INTUBATION, MEDICAL STAFF NOTICED THE CUFF WAS DEFLATED. THE PATIENT WAS REINTUBATED WITH A NEW TUBE. NO HARM OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT. AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCED 3 DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS REFER TO 3004748541-2026-00020 FOR THE SECOND REPORT. REFER TO 3004748541-2026-00021 FOR THE THIRD REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483403 PARKER FLEX-TIP PARKER FLEX-TIP TRACHEAL TUBE WITH STYLET, HIGH VOLUME LOW PRESSURE, CUFFED BTR WELL LEAD MEDICAL CO., LTD. I-PFST-75 (H-PFST-75) UNKNOWN 10749065801753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown