BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT

    MDR report key: 7126076 · Received December 18, 2017

    Report

    Report Number
    1710034-2017-00461
    Event Type
    Injury
    Date Received
    December 18, 2017
    Date of Event
    November 24, 2017
    Report Date
    January 5, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K102520
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    EIGHTY SAMPLE UNITS WITHIN SEALED PACKAGES WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON EXAMINATION, NO MECHANICAL OR PHYSICAL DAMAGE WAS OBSERVED ON ANY OF THE COMPONENTS. FUNCTIONALITY TESTING WAS PERFORMED BY MANUALLY DISENGAGING AND RETRACTING THE UNITS. ALL OF THE TESTED UNITS RETRACTED SUCCESSFULLY. BASED ON THE SAMPLE UNIT INVESTIGATION, OUR QUALITY TEAM WAS UNABLE TO CONFIRM THE REPORTED DEFECTS OF SAFETY SHIELD ACTIVATION FAILURE AND NEEDLE STICK INJURY, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY NOTIFICATIONS ON THE PROVIDED BATCH NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS. PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING PROCESS WITH PRESCRIBED VARIABLES AND ATTRIBUTES INSPECTIONS. THESE INSPECTIONS ARE PERFORMED BY OPERATORS AND PROCESS CONTROL TECHNICIANS TO ENSURE ANY GROSS PROCESS CHANGES ARE IDENTIFIED. ALL SAMPLES AND CHALLENGES WERE PERFORMED AS INTENDED AND NONE RELATING TO THE FUNCTION OF THE SAFETY MECHANISM. NO QNS WERE INITIATED FOR FAILURE OF THE SAFETY MECHANISM. THE CAUSE OF THE SAFETY MECHANISM FAILURE CAN BE ALIGNMENT OF THE MACHINE DURING ASSEMBLY. THE OCCURRENCE AND SEVERITY OF THIS INCIDENT DOES NOT EXCEED WHAT IS ALLOWABLE REPRESENTATIVE SAMPLE ANALYSIS: NO DEFECTS WERE IDENTIFIED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY NOTIFICATIONS ON THE PROVIDED BATCH NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS OF SAFETY SHIELD ACTIVATION FAILURE AND NEEDLE STICK INJURY. 80 SAMPLE UNITS WITHIN SEALED PACKAGES WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON EXAMINATION, NO MECHANICAL OR PHYSICAL DAMAGE WAS OBSERVED TO ANY OF THE COMPONENTS. FUNCTIONALITY TESTING WAS PERFORMED BY MANUALLY DISENGAGING AND RETRACTING THE UNITS. ALL OF THE TESTED UNITS RETRACTED WITHIN SPECIFICATIONS. BASED ON THE SAMPLE UNIT INVESTIGATION, OUR QUALITY TEAM WAS UNABLE TO CONFIRM THE REPORTED DEFECTS AND THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING PROCESS WITH PRESCRIBED VARIABLES AND ATTRIBUTES INSPECTIONS. THESE INSPECTIONS ARE PERFORMED BY OPERATORS AND PROCESS CONTROL TECHNICIANS TO ENSURE ANY GROSS PROCESS CHANGES ARE IDENTIFIED.

    Description of Event or Problem · 1

    WHEN USING THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT A NURSE HAD INSERTED A PINK NEXIVA CANNULA INTO A PATIENT. SHE THEN STARTED THE REMOVAL PROCESS OF THE NEEDLE AND PULLED THE NEEDLE BUT DID NOT HEAR A 'CLICK' FROM THE SAFETY ACTIVATION DEVICE. WHEN PLACING THE NEEDLE IN SHARPS BIN, THE GREY SAFETY ACTIVATION WAS NOT ACTIVATED AND SLID DOWN TO THE BASE A NEEDLE-STICK INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906094 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT INTRAVASCULAR CATHETER SINGLE PORT FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7131593 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention