BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER FLEX-TIP

    MDR report key: 22945090 · Received September 2, 2025

    Report

    Report Number
    3000219639-2025-00057
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    July 14, 2025
    Report Date
    September 2, 2025
    Manufacturer
    PARKER MEDICAL
    Product Code
    BTR
    UDI-DI
    10749065011701
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION-INVESTIGATION COMPLETION: H2; H6. FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED PRODUCT, BY THE DISTRIBUTOR; THE TEST RESULTS CONFIRMED THERE WAS AN AIR LEAK IN THE CUFF; THE REPORTED ISSUE, OF AIR LEAK WAS CONFIRMED; HOWEVER, THE ROOT CAUSE WAS NOT DETERMINED. A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE DOCUMENTED UDI IS BASED ON THE STOCK/PRODUCT CODE PROVIDED BY THE REPORTER; THE UDI-PI IS NOT AVAILABLE AS NO LOT NUMBER WAS PROVIDED 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 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.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE DOCUMENTED UDI IS BASED ON THE STOCK/PRODUCT CODE PROVIDED BY THE REPORTER; THE UDI-PI IS NOT AVAILABLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 02 SEP 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: AFTER THE OPERATION WAS COMPLETED, THE MEDICAL STAFF NOTICED THAT AIR LEAK HAD OCCURRED, THE PATIENT WAS NOT REINTUBATED. THERE WAS NO HARM OR INJURY REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED: AFTER THE OPERATION WAS COMPLETED, THE MEDICAL STAFF NOTICED THAT AIR LEAK HAD OCCURRED, THE PATIENT WAS NOT REINTUBATED. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248631 PARKER FLEX-TIP ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 7.0MM BTR PARKER MEDICAL H-PFHV-70 UNKNOWN 10749065011701

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown