BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-IO 25MM NEEDLE (EA)

    MDR report key: 8941829 · Received August 28, 2019

    Report

    Report Number
    3011137372-2019-00257
    Event Type
    Injury
    Date Received
    August 28, 2019
    Date of Event
    August 2, 2019
    Report Date
    August 5, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FMI
    PMA / PMN Number
    K091140
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE DHR FILE IS NOT AVAILABLE FOR REVIEW IN THE US. RECEIVED ONE (1) EZ-IO NEEDLE CANNULA FROM 9001-VC-001 EZ-IO 25MM NEEDLE (EA) SET FOR INVESTIGATION. UPON RECEIPT A VISUAL INSPECTION WAS PERFORMED TO DETERMINE IF THE COMPLAINT SAMPLE HAD BEEN SUBJECTED TO ANY SIGNS OF ABUSE/MISUSE/DAMAGE. THE CANNULA WAS RECEIVED WITH THE METAL SHAFT DETACHED FROM THE CANNULA HUB; THE HUB END OF THE CANNULA SHAFT WAS SMASHED. DAMAGE WAS ALSO NOTED ON THE PATIENT END OF THE CANNULA NEEDLE. A SECTION OF THE IFU WILL BE REFERENCED AS PART OF THIS INVESTIGATION REPORT. THE IFU STATES, "ATTACH LUER-LOCK SYRINGE TO HUB OF CATHETER. WITHDRAW THE CATHETER BY APPLYING TRACTION WHILE ROTATING THE SYRINGE AND CATHETER CLOCKWISE. MAINTAIN AXIAL ALIGNMENT DURING REMOVAL. DO NOT ROCK OR BEND THE CATHETER." THE CERTIFICATE OF COMPLIANCE COULD NOT BE REVIEWED AS A LOT/BATCH WAS NOT REPORTED. THE COMPLAINT HAS BEEN CONFIRMED, HOWEVER THE LACK OF REPORTED DETAILS/PHOTOS PREVENTS THE ASSIGNMENT OF A DEFINITIVE ROOT CAUSE. NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE ASSIGNED. THE COMPLAINT HAS BEEN CONFIRMED. HOWEVER THE LACK OF REPORTED DETAILS/PHOTOS PREVENTS THE ASSIGNMENT OF A DEFINITIVE ROOT CAUSE. C LOSE EXAMINATION OF THE CANNULA NEEDLE AND HUB DOES NOT REVEAL ANY SIGNS THAT THE REPORTED FAILURE WAS THE CAUSE OF A MANUFACTURING ANOMALY. NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE NO ISSUES KNOWN DURING INSERTION. FLUIDS INFUSED WITHOUT DIFFICULTY BUT WOULD NOT DRAW BLOOD. TEAM ALSO INSERTING A FEMORAL LINE AND ONCE ACHIEVED AND VERIFIED SUCCESSFUL, DECISION MADE TO REMOVE THE IO FROM RIGHT LEG. STAFF ATTACHED SYRINGE TO YELLOW CAP AND DURING REMOVAL THE CAP HOUSING AND NEEDLE SEPARATED LEAVING THE NEEDLE IN THE PATIENT'S LEG. VICE GRIPS WERE OBTAINED TO ASSIST IN REMOVING THE NEEDLE FROM THE PATIENT'S LEG. I HAVE THE NEEDLE AND THE HOUSING ON THE SYRINGE. THE NEEDLE HOWEVER IS NOW CRIMPED FLAT FROM THE VICE GRIPS WHERE IT WOULD HAVE BEEN HOUSED IN THE YELLOW CAP AND UNFORTUNATELY DO NOT HAVE ANY PACKAGING FOR LOT NUMBER DUE TO ROOM SWEPT PRIOR TO REMOVAL.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVESTIGATION IS PENDING. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE NO ISSUES KNOWN DURING INSERTION. FLUIDS INFUSED WITHOUT DIFFICULTY BUT WOULD NOT DRAW BLOOD. TEAM ALSO INSERTING A FEMORAL LINE AND ONCE ACHIEVED AND VERIFIED SUCCESSFUL, DECISION MADE TO REMOVE THE IO FROM RIGHT LEG. STAFF ATTACHED SYRINGE TO YELLOW CAP AND DURING REMOVAL THE CAP HOUSING AND NEEDLE SEPARATED LEAVING THE NEEDLE IN THE PATIENT'S LEG. VICE GRIPS WERE OBTAINED TO ASSIST IN REMOVING THE NEEDLE FROM THE PATIENT'S LEG. I HAVE THE NEEDLE AND THE HOUSING ON THE SYRINGE. THE NEEDLE HOWEVER IS NOW CRIMPED FLAT FROM THE VICE GRIPS WHERE IT WOULD HAVE BEEN HOUSED IN THE YELLOW CAP AND UNFORTUNATELY DO NOT HAVE ANY PACKAGING FOR LOT NUMBER DUE TO ROOM SWEPT PRIOR TO REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735822 EZ-IO 25MM NEEDLE (EA) NEEDLE, HYPODERMIC, SINGLE LU FMI TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention