BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA

    MDR report key: 20698708 · Received November 15, 2024

    Report

    Report Number
    1710034-2024-01355
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    October 31, 2024
    Report Date
    December 19, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835324
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. ADDITIONAL LOT NUMBER WAS PROVIDED IN THIS COMPLAINT FOR MATERIAL NUMBER 383532. LOT # 4030914 MNF DATE 2024-01-30 EXP DATE 2027-01-31 AND LOT # 4088963 MNF DATE 2024-03-28 EXP DATE 2027-03-31.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383532 AND LOT NUMBER 3354911. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR TEAM HAS REPORTED THAT THE NEXIVA 22G IS EXPERIENCING LEAKING FROM THE CLEVIS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143952 BD NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3354911 00382903835324

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown