BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿

    MDR report key: 8303242 · Received February 4, 2019

    Report

    Report Number
    1710034-2019-00140
    Event Type
    Malfunction
    Date Received
    February 4, 2019
    Date of Event
    January 14, 2019
    Report Date
    March 22, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING DHR REVIEW: 1 NON-RELATED QN WAS INITIATED DURING PRODUCTION AL OTHER CHALLENGE, SET UP AND IN-PROCESS SAMPLES WERE PERFORMED AND PASSED PER SPECIFICATIONS. RECEIVED ONE 18GA NEXIVA CATHETER ADAPTER EXTENSIONS SET WITHIN AN OPEN PACKAGE FROM LOT NUMBER: 8232654, THE REMAINDER OF THE UNIT (NEEDLE ASSEMBLY) WAS NOT RETURNED FOR EVALUATION. THE EXTENSION TUBING WAS DISCONNECTED FROM THE PORT OF THE WINGED ADAPTER. TRACES OF ADHESIVE RESIDUE WERE PRESENT ON THE OUTER RIM OF THE WING ADAPTER PORT. MINIMAL TRACES OF ADHESIVE WERE OBSERVED ON THE EXTENSION TUBING. HE 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 A BD NEXIVA¿ EXPERIENCED SEPARATION BETWEEN INSERTER AND TUBING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 A BD NEXIVA¿ EXPERIENCED SEPARATION BETWEEN INSERTER AND TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94593 BD NEXIVA¿ PERIPHERAL VASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8232654 30382903835196

    Patients

    Seq Age Sex Outcome Treatment
    1 Other