BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER FLEX-TIP

    MDR report key: 22691740 · Received August 1, 2025

    Report

    Report Number
    3004748541-2025-00041
    Event Type
    Malfunction
    Date Received
    August 1, 2025
    Report Date
    August 1, 2025
    Manufacturer
    WELL LEAD MEDICAL CO
    Product Code
    BTR
    UDI-DI
    10749065191700
    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

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION. PHOTOGRAPHIC EVIDENCE PROVIDED; THE COMPLAINT WAS CONSIDERED CONFIRMED BASED ON CUSTOMER NARRATIVE OF EVENTS. 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 01 AUG 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 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 AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED, AUTOMATIC CUFF PRESSURE GAUGE ALARMED FREQUENTLY AND RE-INTUBATION WAS PERFORMED. AFTER CHECKING FOR LEAKS BY DIPPING THE CUFF IN WATER, A PINHOLE-SIZED HOLE WAS FOUND IN THE CUFF. IT WAS ADDITIONALLY REPORTED; AN ANCHOR FAST WAS USED DURING INTUBATION. POSITION CHANGED EVERY 2-3 HOURS TO LEFT AND RIGHT. THE TUBE POSITION WAS CHANGED LEFT OR RIGHT WITH ANCHOR FAST IN USE. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1115188 PARKER FLEX-TIP TRACH-VAC WITH FLEX-TIP, PVC CUFF & STYLET, PARKER, 7.0MM, BOX/10, CASE/100 BTR WELL LEAD MEDICAL CO I-PFTVVCS-70-100 UNKNOWN 10749065191700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown