BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-IO 15MM NEEDLE SET + STABILIZER(BOX O

    MDR report key: 12407039 · Received September 1, 2021

    Report

    Report Number
    3011137372-2021-00230
    Event Type
    Malfunction
    Date Received
    September 1, 2021
    Date of Event
    August 19, 2021
    Report Date
    August 30, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FMI
    UDI-DI
    10801902170498
    PMA / PMN Number
    K101026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE MANUFACTURING DHR FILE WAS REVIEWED. NO RECORDED RESULTS OF MANUFACTURING ISSUES OR ANOMALIES WERE REPORTED. CERTIFICATE OF COMPLIANCE (PART OF DHR) CERTIFIES THAT THE AFOREMENTIONED LOT MEETS THE VIANT UPLAND QUALITY SYSTEM REQUIREMENTS AND SPECIFICATIONS. THIS PRODUCT HAS BEEN MANUFACTURED AND CONTROLLED BY VIANT UPLAND IN ACCORDANCE WITH THE FDA QSR AND ISO ISO13485:2016. A REVIEW OF THE CERTIFICATE OF CONFORMANCE/DEVICE HISTORY RECORD FOUND THAT THE NEEDLE SET PASSED ALL THE RELEASE CRITERIA. THE DEVICE WAS RELEASED IN 02/2021 AND IS APPROXIMATELY 0.5 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 FROM THE CUSTOMER PHOTO. 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 FROM THE CUSTOMER PHOTO. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED THREE PHOTOS FOR EVALUATION; REFERENCE (B)(4). THE FIRST PHOTO REVEALED AN OPENED KIT WITH A LOOSE NEEDLE GUARD AND THE SECOND PHOTO REVEALED THE PRODUCT LIDSTOCK FROM WHICH THE LOT NUMBER WAS ABLE TO BE CONFIRMED. THE THIRD PHOTO REVEALED PUNCTURE HOLES IN THE PACKAGING. COMPLAINT CONFIRMED. BASED ON THE CUSTOMER DESCRIPTION AND PHOTOS RETURNED, THIS COMPLAINT IS LIKELY RELATED TO PACKAGE DESIGN. CERTIFICATE OF COMPLIANCE (PART OF DHR) CERTIFIES THAT THE AFOREMENTIONED LOT MEETS THE VIANT UPLAND QUALITY SYSTEM REQUIREMENTS AN D SPECIFICATIONS. THIS PRODUCT HAS BEEN MANUFACTURED AND CONTROLLED BY VIANT UPLAND IN ACCORDANCE WITH THE FDA QSR AND ISO ISO13485:2016. A REVIEW OF THE CERTIFICATE OF CONFORMANCE/DEVICE HISTORY RECORD FOUND THAT THE NEEDLE SET PASSED ALL THE RELEASE CRITERIA. THE DEVICE WAS RELEASED IN 02/2021 AND IS APPROXIMATELY 0.5 YEARS OLD. CORRECTIVE ACTIONS FOR A CAPA WERE IMPLEMENTED IN SEP 2021. THIS EZ-IO KIT WAS MANUFACTURED IN FEB 2021, PRIOR TO THE CORRECTIVE ACTIONS BEING IMPLEMENTED. THE COMPLAINT OF A GUARD BECOMING REMOVED FROM ITS NEEDLE WHILE STILL IN THE KIT WAS ABLE TO BE CONFIRMED BY THE RETURNED CUSTOMER PHOTOS. ONE PHOTO DISPLAYED A LOOSE GUARD AND THE OTHER CONFIRMED THERE WERE PUNCTURE HOLES FROM THE NEEDLE IN THE PACKAGING. THE LIKELY CAUSE OF THIS COMPLAINT IS THE PACKAGE DESIGN. CORRECTIVE ACTIONS FOR A CAPA WERE IMPLEMENTED IN SEP 2021. THIS EZ-IO KIT WAS MANUFACTURED IN FEB 2021, PRIOR TO THE CORRECTIVE ACTIONS BEING IMPLEMENTED.

    Description of Event or Problem · 0

    THE NEEDLE COVER WAS OFF THE NEEDLE WHILE IN THE PACKAGE AND STRUCK THE EMPLOYEE THROUGH THE PACKAGE WHILE UNOPENED.

    Description of Event or Problem · 0

    THE NEEDLE COVER WAS OFF THE NEEDLE WHILE IN THE PACKAGE AND STRUCK THE EMPLOYEE THROUGH THE PACKAGE WHILE UNOPENED.

    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 NEEDLE COVER WAS OFF THE NEEDLE WHILE IN THE PACKAGE AND STRUCK THE EMPLOYEE THROUGH THE PACKAGE WHILE UNOPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1309019 EZ-IO 15MM NEEDLE SET + STABILIZER(BOX O NEEDLE, HYPODERMIC, SINGLE LU FMI TELEFLEX MEDICAL IPN917337 7436193 10801902170498

    Patients

    Seq Age Sex Outcome Treatment
    1 N/A.| N/A.