BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-IO 25MM NEEDLE SET + STABILIZER(BOX O

    MDR report key: 8608847 · Received May 14, 2019

    Report

    Report Number
    3011137372-2019-00156
    Event Type
    Malfunction
    Date Received
    May 14, 2019
    Date of Event
    May 6, 2019
    Report Date
    May 7, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FMI
    PMA / PMN Number
    K091140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING THAT ATHLONE LEGAL MANUFACTURER HAS OPENED AN NC TO ADDRESS THE CONDITION OF THE DISLODGED NEEDLE CAP. THERE WAS NO VISUAL EVIDENCE THAT THE NEEDLE PROTRUDED THROUGH THE POUCH.

    Additional Manufacturer Narrative · 0

    (B)(4). THE DHR FILE IS NOT AVAILABLE FOR REVIEW IN THE US. ONE (1) EZ-IO NEEDLE SET 9001P-VC-005 (LOT/BATCH 5988731) WAS RECEIVED IN ITS ORIGINAL PACKAGING FOR INVESTIGATION. UPON RECEIPT, THE NEEDLE SET WAS VISUALLY INSPECTED. THE NEEDLE SET SHEATH WAS LOOSE IN THE PACKAGING. THE COMPLAINT HAS BEEN CONFIRMED, HOWEVER THE ROOT CAUSE CANNOT BE ESTABLISHED. THE CERTIFICATE OF COMPLIANCE CERTIFIES THAT THE AFOREMENTIONED LOT MEETS THE LAKE REGION MEDICAL QUALITY SYSTEM REQUIREMENTS AND SPECIFICATIONS. THIS PRODUCT HAS BEEN MANUFACTURED AND CONTROLLED BY LAKE REGION MEDICAL IN ACCORDANCE WITH THE FDA QSR AND ISO (B)(4). ONE (1) EZ-IO NEEDLE SET 9001P-VC-005 (LOT/BATCH 5988731) WAS RECEIVED BAG FOR INVESTIGATION. UPON RECEIPT THE NEEDLE SET WAS VISUALLY INSPECTED. THE NEEDLE SET SHEATH WAS LOOSE IN THE ORIGINAL PACKAGING. THE COMPLAINT HAS BEEN CONFIRMED, HOWEVER THE ROOT CAUSE CANNOT BE ESTABLISHED. NO PREVENTATIVE/CORRECTIVE ACTIONS WILL BE ASSIGNED. ONE (1) EZ-IO NEEDLE SET 9001P-VC-005 (LOT/BATCH 5988731) WAS RECEIVED IN ITS ORIGINAL PACKAGING FOR INVESTIGATION. UPON RECEIPT, THE NEEDLE SET WAS VISUALLY INSPECTED. THE NEEDLE SET SHEATH WAS LOOSE IN THE PACKAGING. THE COMPLAINT HAS BEEN CONFIRMED, HOWEVER THE ROOT CAUSE CANNOT BE ESTABLISHED. THERE IS SOME PROCESS VARIATION IN THE ASSEMBLY OF THE CAP TO THE NEEDLE. HOWEVER, SHIPPING AND HANDLING COULD NOT BE ELIMINATED AS A POTENTIAL ROOT CAUSE. BASED ON THE LOW VOLUME OF REPORTED COMPLAINTS OVER THE LAST YEAR, THIS APPEARS TO BE AN ISOLATED ISSUE. WE WILL CONTINUE TO MONITOR AND TREND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CAP OR GUARD CAME OFF ONE OF THE NEEDLES. WHEN THE FIREMAN REACHED INTO THE CABINET TO RETRIEVE, HE GOT STUCK BY THE NEEDLE. THEY DID A CHECK AND FOUND ANOTHER ONE THAT THE CAP OR GUARD WAS OFF BUT THERE WAS NO HARM WITH THE SECOND ONE.

    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

    IT WAS REPORTED THAT THE CAP OR GUARD CAME OFF ONE OF THE NEEDLES. WHEN THE FIREMAN REACHED INTO THE CABINET TO RETRIEVE, HE GOT STUCK BY THE NEEDLE. THEY DID A CHECK AND FOUND ANOTHER ONE THAT THE CAP OR GUARD WAS OFF BUT THERE WAS NO HARM WITH THE SECOND ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400609 EZ-IO 25MM NEEDLE SET + STABILIZER(BOX O NEEDLE, HYPODERMIC, SINGLE LU FMI TELEFLEX MEDICAL 5988731

    Patients

    Seq Age Sex Outcome Treatment
    1