BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARKER FLEX TIP

    MDR report key: 22692865 · Received August 1, 2025

    Report

    Report Number
    3000219639-2025-00053
    Event Type
    Death
    Date Received
    August 1, 2025
    Report Date
    August 1, 2025
    Manufacturer
    PARKER MEDICAL
    Product Code
    BTR
    UDI-DI
    10749065011701
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    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 WAS RETURNED TO THE VENDOR FOR EVALUATION; ADDITIONALLY, A PHOTOGRAPH WAS PROVIDED. BASED ON THE INVESTIGATION PERFORMED BY THE VENDOR AND REVIEW OF THE PHOTOGRAPH THE CUFF WAS VERIFIED TO BE DAMAGED; THE COMPLAINT IS CONSIDERED CONFIRMED. 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 A LEAK OCCURRED FROM THE CUFF DURING INTUBATION OF THE PATIENT WITH HEART FAILURE. THE DOCTOR PERFORMED BASIC LIFE SUPPORT AND INTUBATED THE TUBE AFTER THE PATIENT HAD GONE INTO CARDIOPULMONARY ARREST. ONCE AN ALARM SOUNDED THAT THE CIRCUIT HAD BEEN DISCONNECTED, BUT THE ALARM STOPPED WHEN AIR WAS INJECTED INTO THE CUFF. AFTER THE PATIENT DIED, A COMPUTED TOMOGRAPHY SCAN (CT) SCAN OF THE INTUBATION REVEALED NO ABNORMALITIES; UPON RETURNING TO THE INTENSIVE CARE UNIT (ICU), IT WAS CONFIRMED THAT AIR WAS LEAKING FROM THE CUFF OF THE ENDOTRACHEAL TUBE. IT WAS ADDITIONALLY REPORTED, THE HOSPITAL BELIEVED THE PATIENT DIED BECAUSE SHE WAS NOT WELL TO BEGIN WITH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920450 PARKER FLEX TIP ENDOTRACHEAL TUBE, HIGH VOLUME/LOW PRESSURE (PFHV), CUFFED, PARKER BTR PARKER MEDICAL H-PFHV-70 UNKNOWN 10749065011701

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female