BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA

    MDR report key: 18993582 · Received March 28, 2024

    Report

    Report Number
    1710034-2024-00252
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    February 28, 2024
    Report Date
    June 10, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835119
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL LOT NUMBERS WERE PROVIDED IN THIS COMPLAINT FOR MATERIAL NUMBER 383511. LOT # 3087425; MNF DATE 29 MAR 2023; EXP DATE 31 MAR 2026. LOT # 3040439; MNF DATE 14 FEB 2023; EXP DATE 31 JAN 2026.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383511 AND LOT NUMBER 3040439, 3087425, 2045799. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    INTERNAL RECORD REVIEW CONDUCTED. AWARE DATE FOR THIS COMPLAINT HAS BEEN CORRECTED TO REFLECT (B)(6) 2024.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA HAS FOREIGN MATTER ON ITS TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE TIP OF THE CATHETER IS BURRED AND NOT SMOOTH, THE SAFETY PROTECTION DEVICE IS TOO TIGHT TO START PROPERLY, THERE ARE BURRS ON THE CATHETER WALL, AND THERE ARE BLACK SPOTS ON THE CATHETER WALL

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027848 BD NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3087425 00382903835119

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown