BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER FLEX-TIP

    MDR report key: 22146991 · Received June 4, 2025

    Report

    Report Number
    3000219639-2025-00041
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Report Date
    June 4, 2025
    Manufacturer
    SALTER LABS
    Product Code
    BTR
    UDI-DI
    10749065031709
    PMA / PMN Number
    EXEMPT
    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: G1; H6 THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION; WITHOUT A SAMPLE TO PERFORM FUNCTIONAL EVALUATION OR PHOTOGRAPHIC /VIDEO EVIDENCE THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD IS NOT AVAILABLE AS THE DEVICE IS EXTERNALLY MANUFACTURED. ALL INFORMATION REASONABLY KNOWN AS OF 04 JUN 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, IMMEDIATELY AFTER INTUBATING THE SURGICAL PATIENT (WHO WAS IN THE SUPINE POSITION), A LEAK OCCURRED. (NO PRE-INTUBATION LEAK CHECK WAS PERFORMED.) THE DEVICE WAS REMOVED AND A DIFFERENT TRACHEAL TUBE WAS REINTUBATED, AND THERE WAS NO PROBLEM. THE REPORTER VERIFIED THAT THE LOWER PART OF THE CUFF WAS DAMAGED AND CONFIRMED THE LEAK. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886078 PARKER FLEX-TIP ENDOTRACHEAL TUBE, PREFORMED NASAL, HIGH VOLUME LOW PRESSURE, CUFFED BTR SALTER LABS H-PFNC-70 2410NC2948K 10749065031709

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown