BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NEXIVA HF Y

    MDR report key: 8139721 · Received December 6, 2018

    Report

    Report Number
    1710034-2018-00883
    Event Type
    Malfunction
    Date Received
    December 6, 2018
    Date of Event
    November 20, 2018
    Report Date
    February 27, 2019
    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
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR- THE LOT NUMBER WAS BUILT/PACKAGED ON NFA LINE 1 FROM 26AUG2018 THRU 05SEPT2018. ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE CONTROL PLANS. QN: (B)(4) (KINKED TUBING) AND QN: (B)(4) (MISSING PRINT-PKG) WERE INITIATED DURING PRODUCTION. DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTION WERE APPLIED PER QUALITY PLANS. RECEIVED A TOTAL OF 145 NEXIVA 20GA UNITS. ALL UNITS WERE WITHIN SEALED PACKAGES FROM LOT NUMBER: 8235504. ALL COMPONENTS OF THE UNITS WERE INTACT. THE EXTENSION TUBINGS WERE MANUALLY PULLED IN AN ATTEMPT TO DISCONNECT THEM FROM THE WINGED ADAPTER PORT: DISCONNECTION OCCURRED ON 14 OF THE ASSEMBLIES RECEIVED. PROBABLE ROOT CAUSE-MANUFACTURING: 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 THE TUBING OF BD¿ NEXIVA HF Y WAS SEPARATED FROM A ADAPTOR DURING USE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.(B)(6). 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 THE TUBING OF BD¿ NEXIVA HF Y WAS SEPARATED FROM A ADAPTOR DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980149 BD¿ NEXIVA HF Y PERIPHERAL VASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8235504 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other