BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-IO INTRAOSSEOUS INFUSION SYSTEM NEEDLE SET

    MDR report key: 10442892 · Received August 24, 2020

    Report

    Report Number
    3011137372-2020-00182
    Event Type
    Malfunction
    Date Received
    August 24, 2020
    Date of Event
    July 18, 2020
    Report Date
    August 7, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FMI
    PMA / PMN Number
    K091140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DHR FILE IS NOT AVAILABLE FOR REVIEW. THE ATTACHED CERTIFICATE OF COMPLIANCE CERTIFIES THAT THE AFOREMENTIONED LOT MEETS THE LAKE REGION MEDICAL (VIANT) QUALITY SYSTEM REQUIREMENTS AND SPECIFICATIONS. THIS PRODUCT HAS BEEN MANUFACTURED AND CONTROLLED BY LAKE REGION MEDICAL (VIANT) IN ACCORDANCE WITH THE FDA QSR AND ISO 13485:2003. A REVIEW OF THE CERTIFICATE OF CONFORMANCE FOUND THAT THE NEEDLE SET PASSED ALL THE RELEASE CRITERIA. THE DEVICE WAS RELEASED IN 11/2017 AND IS APPROXIMATELY 3 YEARS OLD. THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR RETURN. FUNCTIONAL TESTING AND INVESTIGATION ACTIVITIES CANNOT BE CONDUCTED. THE COMPLAINT ROOT CAUSE CANNOT BE ESTABLISHED. THE COMPLAINT CANNOT BE CONFIRMED. NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE ASSIGNED. THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR RETURN. FUNCTIONAL TESTING AND INVESTIGATION ACTIVITIES CANNOT BE CONDUCTED. THE COMPLAINT ROOT CAUSE CANNOT BE ESTABLISHED. THE COMPLAINT CANNOT BE CONFIRMED. NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 0

    THE REPORT STATES: ON SATURDAY (B)(6) 2020, WE HAD A PATIENT WHO WAS VITAL SIGNS ABSENT BROUGHT IN BY AMBULANCE TO THE EMERGENCY DEPARTMENT. WE RAN A CODE IN THE DEPARTMENT. THE PATIENT HAD A PROCEDURE EARLY IN THE DAY AT A DIFFERENT HEALTH CARE FACILITY, SO IT WAS A CORONER'S CASE. DURING THE RESUSCITATION, THE EMERGENCY PHYSICIAN INSERTED AN IO. THE PHYSICIAN ANOTHER 2 NURSES WERE UNABLE TO REMOVE THE CORE NEEDLE(25MM BLUE IO). FOR THE SAKE OF TIME, WE ENDED UP JUST INSERTING A SECOND IO OF THE SAME STYLE. THE CORE CAME OUT AS EXPECTED ON THE SECOND IO. I REPORTED THIS TO THE CORONER WHO LOOKED AT THE IO DURING HIS EXAMINATION. HE WAS ALSO UNABLE TO REMOVE THE CORE NEEDLE. IT APPEARS THAT IT WAS ACTUALLY FUSED TOGETHER, MAKING IT A MEDICAL EQUIPMENT FAILURE. DURING THE TIME THAT WE WERE CLEANING UP THE ROOM WE DIDN'T REALIZE IT WAS AN EQUIPMENT FAILURE SO WE DIDN'T KEEP THE PACKAGING. THE 2 LOT NUMBERS ARE 5971671 AND 5151075.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    THE REPORT STATES: ON SATURDAY (B)(6) 2020, WE HAD A PATIENT WHO WAS VITAL SIGNS ABSENT BROUGHT IN BY AMBULANCE TO THE EMERGENCY DEPARTMENT. WE RAN A CODE IN THE DEPARTMENT. THE PATIENT HAD A PROCEDURE EARLY IN THE DAY AT A DIFFERENT HEALTH CARE FACILITY, SO IT WAS A CORONER'S CASE. DURING THE RESUSCITATION, THE EMERGENCY PHYSICIAN INSERTED AN IO. THE PHYSICIAN ANOTHER 2 NURSES WERE UNABLE TO REMOVE THE CORE NEEDLE(25MM BLUE IO). FOR THE SAKE OF TIME, WE ENDED UP JUST INSERTING A SECOND IO OF THE SAME STYLE. THE CORE CAME OUT AS EXPECTED ON THE SECOND IO. I REPORTED THIS TO THE CORONER WHO LOOKED AT THE IO DURING HIS EXAMINATION. HE WAS ALSO UNABLE TO REMOVE THE CORE NEEDLE. IT APPEARS THAT IT WAS ACTUALLY FUSED TOGETHER, MAKING IT A MEDICAL EQUIPMENT FAILURE. DURING THE TIME THAT WE WERE CLEANING UP THE ROOM WE DIDN'T REALIZE IT WAS AN EQUIPMENT FAILURE SO WE DIDN'T KEEP THE PACKAGING. THE 2 LOT NUMBERS ARE 5971671 AND 5151075.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908104 EZ-IO INTRAOSSEOUS INFUSION SYSTEM NEEDLE SET NEEDLE, HYPODERMIC, SINGLE LU FMI TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1