BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 12869794 · Received November 24, 2021

    Report

    Report Number
    1710034-2021-01018
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    October 28, 2021
    Report Date
    December 6, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835325
    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

    H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED TWO PHOTOGRAPHS WHICH DISPLAYED THE TOP WEB (LABEL) AND BOTTOM WEB (BLISTER) OF TWO UNDAMAGED SEALED UNIT PACKAGES FROM PRODUCT 22GA BD NEXIVA CLOSED IV CATHETER SYSTEM-DUAL PORT, REFERENCE NUMBER 383532, LOT NUMBER 1082130. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCE ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE UNITS ARE WITH ALL COMPONENTS PRESENT LESS THE PINCH CLAMP. IN ADDITION, THE UNITS RETURNED DISPLAYED SIMILAR CONDITION TO THAT SEEN IN THE PHOTOGRAPHS. THE REPORTED ISSUE WAS CONFIRMED AS THE PINCH CLAMPS ARE MISSING. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO AN OPERATOR ERROR DURING THE INSPECTION PROCESS.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THE TUBE CLAMP WAS MISSING. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE WAS NO CLAMP ASSEMBLED IN THE PRODUCT, WHICH REQUIRED RE-VENIPUNCTURE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THE TUBE CLAMP WAS MISSING. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE WAS NO CLAMP ASSEMBLED IN THE PRODUCT, WHICH REQUIRED RE-VENIPUNCTURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766621 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383532 1082130 30382903835325

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown