BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD NEXIVA¿

    MDR report key: 8265079 · Received January 21, 2019

    Report

    Report Number
    1710034-2019-00003
    Event Type
    Injury
    Date Received
    January 21, 2019
    Date of Event
    January 3, 2019
    Report Date
    April 25, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835196
    PMA / PMN Number
    K102520
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR REVIEW WAS PERFORMED ON LOT NUMBER 8232654; THE LOT NUMBER WAS BUILT / PACKAGED ON NFA LINE 1 FROM 23AUG2018 THRU 26AUG2018 FOR A QUANTITY OF 235,210 UNITS. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. RECEIVED TWO NEXIVA 18GA UNITS IN OPENED PACKAGING FROM CATALOG NUMBER 383519, LOT NUMBER 8232654. ONE UNIT WAS USED AND ONE UNUSED. VISUAL/MICROSCOPIC EVALUATION: USED UNIT: THE EXTENSION TUBING WAS SEPARATED FROM THE WINGED ADAPTER. UNUSED UNIT: THE EXTENSION SET WAS ADHERING TO THE PORT OF THE WINGED ADAPTER. CONCLUSION: MANUFACTURING ¿ THE DEFECT WAS IDENTIFIED AND CONFIRMED TO BE SEPARATION INSERTER FROM TUBING; CATHETER BROKE / SEPARATED BEFORE PLACEMENT WAS CONFIRMED. THE DEVICE FAILURE WAS DUE TO AN INSUFFICIENT AMOUNT OF ADHESIVE IN THE EXTENSION TUBING/ ADAPTER JOINT. THIS DEFECT IS CREATED AT THE NEW ZONE 8 ADHESIVE DISPENSE STATION. WHEN THE ADHESIVE DISPENSES TIPS BECOME MISALIGNED, ADHESIVE IS NOT DISPENSED IN THE PROPER LOCATION LEADING TO AN INSUFFICIENT AMOUNT OF ADHESIVE IN THE TUBING/ADAPTER PORT JOINT. THIS FAILURE MODE OF THE PROCESS WAS INTRODUCED BY THE NEW STATION DESIGN, AND THE 100% ADHESIVE PRESENCE VISION SYSTEM WAS NOT CAPABLE OF DETECTING THESE FAILURES. THE MANUFACTURING DEPARTMENT IDENTIFIED THE ISSUE AND TOOK IMMEDIATE CORRECTIVE ACTION ON 11 SEP 2018 BY UPGRADING THE VISION SYSTEM ON BOTH PRODUCTION LINES TO BE ABLE TO DETECT ADHESIVE THAT WAS NOT IN THE CORRECT LOCATION. HOLDERS FOR THE ADHESIVE DISPENSE TIPS WERE ADDED TO THE MACHINE ON 26 SEP 2018 TO BETTER PROTECT THE TIPS FROM DAMAGE AND BECOMING MISALIGNED. CAPA 684099 HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE BD NEXIVA¿S HAD BROKEN WHILE BEING USED FOR AN IV. THE CUSTOMER SAID "IN THE PAST 48 HOURS, WE HAVE HAD THREE SEPARATE NURSES REPORT THAT THE 18G NEXIVA IV'S CATHETER HAD "FALLEN OFF" WHILE ATTEMPTING TO PLACE AN I.V. THIS PRODUCT DEFECT RESULTED IN A DELAY OF PATIENT CARE IN ALL THREE PATIENT CASES.¿

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE BD NEXIVA¿S HAD BROKEN WHILE BEING USED FOR AN IV. THE CUSTOMER SAID "IN THE PAST 48 HOURS, WE HAVE HAD THREE SEPARATE NURSES REPORT THAT THE 18G NEXIVA IV'S CATHETER HAD "FALLEN OFF" WHILE ATTEMPTING TO PLACE AN I.V. THIS PRODUCT DEFECT RESULTED IN A DELAY OF PATIENT CARE IN ALL THREE PATIENT CASES.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58463 BD NEXIVA¿ PERIPHERAL VASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8232654 30382903835196

    Patients

    Seq Age Sex Outcome Treatment
    1 Other