BEUDAMED
    FDA Adverse Event Death Summary report: N

    EZ-IO 25MM NEEDLE + STABILIZER BX/5 (EU)

    MDR report key: 19020125 · Received April 2, 2024

    Report

    Report Number
    3011137372-2024-00036
    Event Type
    Death
    Date Received
    April 2, 2024
    Date of Event
    February 12, 2024
    Report Date
    March 5, 2024
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTED DATA: SECTION H.11. CORRECTED TO: COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A REVIEW OF THE CERTIFICATE OF COMPLIANCE FOUND THAT THE NEEDLE SET PASSED ALL THE RELEASE CRITERIA. THE IFU PROVIDED WITH THIS KIT STATES, "BEFORE ADMINISTERING VESICANT, TOXIC, OR HIGHLY CONCENTRATED DRUGS, CHECK THE IO CANNULA AGAIN FOR PLACEMENT AND PATENCY" AND "DO NOT RECAP NEEDLE SETS OR RECONNECT SEPARATED COMPONENTS. USE BIOHAZARD AND SHARPS DISPOSAL PRECAUTIONS. RE-USE OF CONTENTS MAY CAUSE CROSS-CONTAMINATION, LEADING TO PATIENT RISK AND COMPLICATION(S)." WITHOUT THE DEVICE TO EVALUATE, THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A REVIEW OF THE CERTIFICATE OF COMPLIANCE FOUND THAT THE DRIVER PASSED ALL THE RELEASE CRITERIA. THE IFU FOR THIS DEVICE STATES, "IMPORTANT: CONTROL PATIENT MOVEMENT PRIOR TO AND DURING PROCEDURE. SQUEEZE TRIGGER AND APPLY GENTLE, STEADY PRESSURE. IMPORTANT: DO NOT USE EXCESSIVE FORCE". WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CLINICAL STAFF THAT: "THE NEEDLE WAS ALREADY DETACHED WHEN IT WAS REMOVED FROM THE PACKAGING, BUT THIS WAS NOT NOTICED DURING RESUSCITATION AND THE INTRAOSSEOUS ACCESS WAS ESTABLISHED ANYWAY. THE IO ACCESS WAS DRILLED BUT WAS NOT ACCESSIBLE BECAUSE ONLY THE BACK PART OF THE NEEDLE WAS IN THE PATIENT, THE FRONT PART WAS STILL IN THE PACKAGING. AS A RESULT, THE APPLICATION OF A MEDICATION (EPINEPHRINE) WAS DELAYED BY APPROXIMATELY 5 MINUTES (TIME TO DETECT THE ISSUE AND NEW INTRAOSSEOUS ACCESS)." IT WAS REPORTED THAT THE PATIENT DIED. ADDITIONAL INFORMATION RECEIVED ON 12MAR2024: THE PATIENT'S DATE OF DEATH IS REPORTED AS (B)(6) 2024. THE TIME INTERVAL FROM WHEN THE ISSUE WAS DETECTED TO DEATH WAS APPROXIMATELY 20 MIN.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CLINICAL STAFF THAT: "THE NEEDLE WAS ALREADY DETACHED WHEN IT WAS REMOVED FROM THE PACKAGING, BUT THIS WAS NOT NOTICED DURING RESUSCITATION AND THE INTRAOSSEOUS ACCESS WAS ESTABLISHED ANYWAY. THE IO ACCESS WAS DRILLED BUT WAS NOT ACCESSIBLE BECAUSE ONLY THE BACK PART OF THE NEEDLE WAS IN THE PATIENT, THE FRONT PART WAS STILL IN THE PACKAGING. AS A RESULT, THE APPLICATION OF A MEDICATION (EPINEPHRINE) WAS DELAYED BY APPROXIMATELY 5 MINUTES (TIME TO DETECT THE ISSUE AND NEW INTRAOSSEOUS ACCESS)." IT WAS REPORTED THAT THE PATIENT DIED. ADDITIONAL INFORMATION RECEIVED ON 12MAR2024 INDICATED THAT THE PATIENT'S DATE OF DEATH WAS (B)(6) 2024 AND THAT THE TIME INTERVAL FROM WHEN THE PRODUCT ISSUE WAS DETECTED TO DEATH WAS APPROXIMATELY 20 MINUTES."

    Description of Event or Problem · 0

    IT WAS REPORTED BY CLINICAL STAFF THAT: "THE NEEDLE WAS ALREADY DETACHED WHEN IT WAS REMOVED FROM THE PACKAGING, BUT THIS WAS NOT NOTICED DURING RESUSCITATION AND THE INTRAOSSEOUS ACCESS WAS ESTABLISHED ANYWAY. THE IO ACCESS WAS DRILLED BUT WAS NOT ACCESSIBLE BECAUSE ONLY THE BACK PART OF THE NEEDLE WAS IN THE PATIENT, THE FRONT PART WAS STILL IN THE PACKAGING. AS A RESULT, THE APPLICATION OF A MEDICATION (EPINEPHRINE) WAS DELAYED BY APPROXIMATELY 5 MINUTES (TIME TO DETECT THE ISSUE AND NEW INTRAOSSEOUS ACCESS)." IT WAS REPORTED THAT THE PATIENT DIED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024 INDICATED THAT THE PATIENT'S DATE OF DEATH WAS (B)(6) 2024 AND THAT THE TIME INTERVAL FROM WHEN THE PRODUCT ISSUE WAS DETECTED TO DEATH WAS APPROXIMATELY 20 MINUTES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362676 EZ-IO 25MM NEEDLE + STABILIZER BX/5 (EU) NEEDLE, HYPODERMIC, SINGLE LUMEN FMI TELEFLEX MEDICAL IPN919698 67498847

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Death NOT REPORTED| NOT REPORTED| NOT REPORTED