BEUDAMED
    FDA Adverse Event Death Summary report: N

    PORTEX TUBES PDT UNIPERC

    MDR report key: 22554746 · Received July 21, 2025

    Report

    Report Number
    3012307300-2025-08620
    Event Type
    Death
    Date Received
    July 21, 2025
    Date of Event
    February 12, 2025
    Report Date
    August 15, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    BTO
    UDI-DI
    15019315060434
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2: DEATH DATE IS UNKNOWN. DEVICE EVALUATION: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    B2: DATE OF DEATH UNKNOWN. H3: NO DEVICE OR DEVICE PHOTO WAS RETURNED FOR INVESTIGATION. ALTHOUGH THE COMPLAINT MENTIONS A PHOTO, ONLY A CATALOGUE IMAGE WAS PROVIDED, NOT A PHOTO OF THE ACTUAL USED PRODUCT. DUE TO THIS, NO ROOT CAUSE WAS DETERMINED. THE DEVICE HISTORY REVIEW OF THE REPORTED LOT NUMBER WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. IF THE PRODUCT IS RETURNED, THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. THE CUSTOMER ALSO HAD REPORTED A POTENTIAL ISSUE RELATED TO THE FLANGE LOCKING MECHANISM. HOWEVER, IT WAS ALSO STATED THAT THE PRODUCT WAS INSERTED INCORRECTLY, WHICH IS THE MOST LIKELY ROOT CAUSE OF THE REPORTED INCIDENT. IT WAS FURTHER NOTED THAT THE TRACHEOSTOMY DISPLACEMENT WAS NOT CONSIDERED TO BE THE DIRECT CAUSE OF THE PATIENT'S DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE BECAME DISPLACED FOLLOWING SURGICAL INSERTION IN ONE OF THE ICU PATIENTS. THE MECHANISM/'CLIP' USED TO SECURE THE TRACHEOSTOMY TUBE ITSELF TO THE FLANGE CAUSED A POTENTIAL SAFETY CONCERN. THE TRACHEOSTOMY WAS MISTAKENLY INSERTED UPSIDE DOWN, WITH THE "CLIP" FACING UPWARDS. THIS RESULTED IN IT BECOMING KNOCKED OPEN WHEN THE PATIENT WAS MOVED. THE TRACHEOSTOMY BECAME DISPLACED AND THE PATIENT RAPIDLY DESATURATED DIFFICULTIES REPLACING IT THROUGH A FRESH STOMA. THE TRACHEOSTOMY BECAME DISPLACED THE MORNING AFTER IT WAS SURGICALLY PLACED ON (B)(6) 2025. IT WAS ALSO DIFFICULT TO RE-INTUBATE HER, BUT SURGICAL ASSISTANCE WAS ON HAND TO PLACE A SMALL (SIZE 6) ENDOTRACHEAL TUBE THROUGH THE TRACHEOSTOMY STOMA PRIOR TO IT BEING FORMALLY REPLACED IN THEATRE. THE PATIENT SUBSEQUENTLY DIED BUT HER DEATH WAS NOT DIRECTLY RELATED TO THE DISPLACED TRACHEOSTOMY. THE STATUS OF THE EVENT IS RESOLVED. THERE WAS PATIENT INVOLVEMENT AND ADVERSE HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737234 PORTEX TUBES PDT UNIPERC TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO ICU MEDICAL, INC. NI 15019315060434

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Unknown Death