BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-IO 45MM NEEDLE SET + STABILIZER(BOX O

    MDR report key: 8930573 · Received August 26, 2019

    Report

    Report Number
    3011137372-2019-00262
    Event Type
    Malfunction
    Date Received
    August 26, 2019
    Date of Event
    July 31, 2019
    Report Date
    August 2, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FMI
    PMA / PMN Number
    K091140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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) 9079P-VC-005 EZ-IO 45MM NEEDLE SET + STABILIZER (BOX O, EZ-IO NEEDLE SET FOR INVESTIGATION. UPON RECEIPT A VISUAL INSPECTION WAS PERFORMED TO DETERMINE IF THE COMPLAINT SAMPLE HAD BEEN SUBJECTED TO ANY ABUSE/MISUSE/DAMAGE. NOTHING NOTED. THE REPORTED DETAILED COMPLAINT DESCRIPTION STATES THE STYLET AND CANNULA ARE "BONDED", "STUCK" TOGETHER AT THE CANNULA AND STYLET MATING HUB INTERFACES. THE REPORTED CONDITION HAS BEEN CONFIRMED. REASONABLE HAND FORCE WILL NOT SEPARATE THE STYLET AND CANNULA. THE NEEDLE SET WAS BROKEN APART IN A VICE WITH PLIERS. PER THE PICTURES ATTACHED, THE THREADS FROM THE STYLET AND CANNULA WERE EXAMINED UNDER MAGNIFICATION. THERE WERE NO VISUAL SIGNS OF DEFECT ANOMALIES SUCH AS PLASTIC THREAD FRACTURE, THREAD PLASTIC ROLL-OVER DUE TO EXCESSIVE TIGHTENING FORCE, AND THE INTERFACE SURFACE DID NOT SHOW ANY EVIDENCE OF A FOREIGN MATERIAL THAT MIGHT HAVE CAUSED A "BONDING" CONDITION. A SECTION OF THE IFU WILL BE REFERENCED AS PART OF THIS INVESTIGATION REPORT. THE IFU STATES, "SQUEEZE THE TRIGGER AND APPLY MODERATE, STEADY PRESSURE. IMPORTANT: DO NOT USE EXCESSIVE FORCE. USE MODERATE, STEADY, DOWNWARD PRESSURE AND ALLOW THE NEEDLE SET TO PENETRATE THE BONE." THE CERTIFICATE OF COMPLIANCE COULD NOT BE REVIEWED , AS A LOT/BATCH WAS NOT REPORTED. IN ADDITION TO THE PICTURES OF THREADS, ANOTHER SET OF PICTURES HAVE BEEN PROVIDED THAT DEPICTS THE CONDITION OF THE STYLET AND CANNULA NEEDLE TIPS. THESE PICTURES DEPICT DAMAGED CANNULA CUTTING TIPS. IN A LAB SETTING, A 45MM NEEDLE SET WAS DRIVEN INTO A HARD SAW BONE MEDIUM WITH EXCESSIVE FORCE. THE SAME RESULTS WERE RENDERED IN THIS TEST NEEDLE AS WAS NOTED IN THE COMPLAINT SAMPLE. IN THE TEST NEEDLE THE STYLET NEEDLE TIP WAS ROLLED OVER AND THE CANNULA CUTTING TIPS WERE ROLLED TO ONE SIDE. THE TEST RESULTS POINT TO THE NEEDLE BEING DRIVEN WITH EXCESSIVE FORCE INTO A VERY HARD TIBIA BONE. THE DRILLING FORCE REQUIRED WAS GREAT ENOUGH TO "BOND" OR "LOCK" THE TWO NEEDLE COMPONENTS TOGETHER. THIS CONDITION IS FURTHER SUBSTANTIATED VIA TC # (B)(4). A 25MM NEEDLE SET (9001P-VC-005) WAS USED ON THE SAME PATIENT, IN THE OTHER LEG TIBIA. WHILE FIELD CLINICIANS QUICKLY REALIZED THIS NEEDLE WAS MUCH TOO SHORT TO ACHIEVE THE KIND OF PENETRATION NEEDED FOR EFFECTIVE INTRAOSSEOUS INFUSION, THIS NEEDLE ALSO "STUCK" OR "BONDED" TOGETHER. THE CIRCUMSTANCES OF THESE TWO SEPARATE INCIDENCES DO NOT SUPPORT A MANUFACTURING PROCESS DEFECT, OR SOME OTHER MANUFACTURING ANOMALY. EVIDENCE DOES NOT SUPPORT THAT TWO UNIQUE PRODUCT CODES, FROM OBVIOUSLY TWO DIFFERENT LOT/BATCHES, BOTH EXPERIENCING THE SAME CONDITION WERE CAUSED BY A MANUFACTURING PROBLEM. NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE ON SCENE OF A CARDIAC ARREST, PARAMEDIC PLACED IO IN PATIENT'S RIGHT PROXIMAL TIBIA. DUE TO THE PATIENTS SIZE THEY USED A 45MM NEEDLE, AFTER PLACEMENT THEY COULD NOT REMOVE THE NEEDLE FROM THE CATHETER. THE DECISION WAS MADE TO REMOVE IT. THEY THEN ATTEMPTED TO PLACE A 25MM NEEDLE IN THE PATIENT'S LEFT PROXIMAL TIBIA, BUT IT WAS NOT LARGE ENOUGH. THEY THEN STUCK A 20G NEEDLE IN THE PATIENTS LEFT ARM. MEDS WERE DELIVERED APPROXIMATELY 6 MINUTES AFTER FAILED IO. PARAMEDICS SAID THE IO MALFUNCTION DID NOT ALTER THE PATIENT'S OUTCOME...THE PATIENT WAS PRONOUNCED DEAD AT 1429.

    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 WHILE ON SCENE OF A CARDIAC ARREST, PARAMEDIC PLACED IO IN PATIENT'S RIGHT PROXIMAL TIBIA. DUE TO THE PATIENTS SIZE THEY USED A 45MM NEEDLE, AFTER PLACEMENT THEY COULD NOT REMOVE THE NEEDLE FROM THE CATHETER. THE DECISION WAS MADE TO REMOVE IT. THEY THEN ATTEMPTED TO PLACE A 25MM NEEDLE IN THE PATIENT'S LEFT PROXIMAL TIBIA, BUT IT WAS NOT LARGE ENOUGH. THEY THEN STUCK A 20G NEEDLE IN THE PATIENTS LEFT ARM. MEDS WERE DELIVERED APPROXIMATELY 6 MINUTES AFTER FAILED IO. PARAMEDICS SAID THE IO MALFUNCTION DID NOT ALTER THE PATIENT'S OUTCOME...THE PATIENT WAS PRONOUNCED DEAD AT 1429.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725039 EZ-IO 45MM NEEDLE SET + STABILIZER(BOX O NEEDLE, HYPODERMIC, SINGLE LU FMI TELEFLEX MEDICAL UNKOWN

    Patients

    Seq Age Sex Outcome Treatment
    1