BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 15180412 · Received August 5, 2022

    Report

    Report Number
    1710034-2022-00422
    Event Type
    Malfunction
    Date Received
    August 5, 2022
    Date of Event
    July 8, 2022
    Report Date
    September 19, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835318
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS PROVIDED FOR EVALUATION. BD RECEIVED THREE PHOTOS AND ONE NEXIVA CLOSED IV CATHETER SYSTEM WITH A BD Q-SYTE IN AN OPENED PACKAGE. UPON VISUAL INSPECTION OF THE COMPONENT, DAMAGE TO THE Q-SYTE WAS FOUND. FURTHER MICROSCOPIC EVALUATION WAS PERFORMED FOR BETTER IMAGE QUALITY AND THE TOP DISK WAS FOUND TO BE PARTIALLY PUSHED IN. PER THE REPORT, THE DEFECT WAS FOUND BEFORE USE AND BECAUSE ADHESIVE COULD NOT BE OBSERVED ON THE TOP BODY NOR SIGNS OF USAGE, IT IS UNLIKELY THAT THE DEFECT OCCURRED IN THE CLINICIAN ENVIRONMENT. DURING MANUFACTURING, LOW BOND STRENGTH (OR INSUFFICIENT ADHESIVE) MAY RESULT IN THE SEPTUM BEING PUSHED IN. OPERATOR-CONTROLLED CHECKS FOR BOND STRENGTH AND SEPTUM DAMAGE ARE PERFORMED TO MITIGATE THE RISK FROM THIS TYPE OF DEFECT. ADDITIONALLY, PREVENTATIVE MAINTENANCE (PM) IS PERFORMED TO ENSURE TOOLING IS REPLACED PER THE QUALITY PLAN AND THE EQUIPMENT IS FUNCTIONING PROPERLY. PM RECORDS WERE VERIFIED TO BE UP TO DATE DURING THE PRODUCTION OF THIS LOT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM EXPERIENCED DISFIGURED/SUNKEN SEPTUM OF Q-SYTE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN CHECKING THE PRODUCT BEFORE USE AFTER UNPACKING THE STERILIZED PACKAGE, THE HCP CONFIRMED AN ABNORMAL FINDING ON THE SEPTUM OF Q-SYTE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM EXPERIENCED DISFIGURED/SUNKEN SEPTUM OF Q-SYTE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN CHECKING THE PRODUCT BEFORE USE AFTER UNPACKING THE STERILIZED PACKAGE, THE HCP CONFIRMED AN ABNORMAL FINDING ON THE SEPTUM OF Q-SYTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1579767 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383531 1154429 30382903835318

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown