BEUDAMED
    FDA Adverse Event Death Summary report: N

    SILICONE - BIVONA TUBES NEO/PED FLEXTEND PLUS

    MDR report key: 16229979 · Received January 23, 2023

    Report

    Report Number
    3012307300-2023-00620
    Event Type
    Death
    Date Received
    January 23, 2023
    Date of Event
    December 1, 2022
    Report Date
    March 29, 2023
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTO
    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

    OTHER, OTHER TEXT: B5: DESCRIBE EVENT OR PROBLEM; D4: CATALOG NUMBER AND H6. EVENT PROBLEM AND EVALUATION CODES: UPDATED. NO ACTUAL PRODUCT WAS RETURNED HOWEVER, THIRTY (30) PHOTOS WERE PROVIDED FOR ANALYSIS WHICH IDENTIFIED A PART NUMBER AND TWO (2) LOT NUMBERS. IT IS NOT KNOWN WHICH PHOTOS ARE RELATED TO THIS COMPLAINT. PHOTO ANALYSIS SHOWED THE FLANGE COMPONENT WAS BROKEN, CONFIRMING THE COMPLAINT. AFTER A REVIEW OF THE DIFFERENT VERIFICATIONS THAT ARE PERFORMED BY PRODUCT PERSONNEL DURING THE MANUFACTURING PROCESS TO DETECT DAMAGED COMPONENTS, THE MOST PROBABLE ROOT CAUSE IS THAT DAMAGE OCCURRED AFTER THE PRODUCT LEFT THE FACILITY. SINCE IT IS UNKNOWN WHICH OF THE IDENTIFIED LOT NUMBERS IS FOR THIS EVENT, A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR BOTH LOT NUMBERS, AND DID NOT IDENTIFY ANY NON-CONFORMANCES OR RELATED ISSUES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER. A CUSTOMER COMPLAINT NOTIFICATION WAS MADE TO RAISE AWARENESS OF THE REPORTED ISSUE, CONDUCTED MARCH 2023.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: DEVICE EVALUATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. UDI#: UNKNOWN. NO LOT OR SERIAL NUMBERS WERE COMMUNICATED; DEVICE EXPIRATION DATE AND H4: DEVICE MANUFACTURING DATE NOT AVAILABLE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. THE DEVICE REMAINS WITH THE POLICE. THE POLICE HAVE ALSO TAKEN POSSESSION OF 5 OTHER TRACHEOSTOMY TUBES BELONGING TO THE SAME PATIENT THAT WERE PREVIOUSLY RETURNED TO THE COMMUNITY NURSE. THESE THEREFORE CANNOT BE RETUNED AT PRESENT. IT HAS BEEN RELAYED THIS TO THE POLICE OF THE NEED TO REVIEW THE TUBES AND INVESTIGATE AS A MATTER OF URGENCY. ADDITIONALLY, THE ACCIDENTAL DECANNULATION WAS NOT WITNESSED. THE PATIENT WAS SLEEPING AND WAS LEFT UNATTENDED FOR ABOUT 5-10 MINUTES. WHEN THE PATIENT MOTHER RETURNED, THE CHILD WAS UNRESPONSIVE WITH THE TRACH TUBE BROKEN AT THE FLANGE. THE FLANGE WAS ENTIRELY SEPARATED FROM THE TUBE. THE TUBE HAD BEEN ROUTINELY CHANGED THE PREVIOUS 24 HOURS AND WAS SECURED WITH VELCRO TIES.

    Description of Event or Problem · 0

    THE SUSPECTED LOT NUMBERS WERE 4075238 AND 3767405.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ACCIDENTAL DECANNULATION, CARDIORESPIRATORY ARREST AND SUBSEQUENT DEATH. CUSTOMER REPORTED THE INCIDENT OCCURRED IN (B)(6) 2022, ULTIMATELY THE TRACHEOSTOMY TUBE FROM THIS COMPLAINT IS BEING HELD BY THE POLICE AND THAT THE MHRA (MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY) AND CORONER'S OFFICE HAVE BEEN INFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408633 SILICONE - BIVONA TUBES NEO/PED FLEXTEND PLUS TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Unknown Death