BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SP WITH MAXZERO

    MDR report key: 21636055 · Received March 18, 2025

    Report

    Report Number
    1710034-2025-00420
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    February 18, 2025
    Report Date
    April 2, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835607
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383560 AND LOT NUMBER 4081120. 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.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA 18 GA X 1.75IN SP WITH MAXZERO LEAKED AT THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL# 383560. BATCH# 4081120. IT WAS REPORTED BY CUSTOMER THAT THE PERSON PLACING THE IV PULLED THE NEEDLE OUT AND BLOOD LEAKED OUT OF THE GRAY RUBBER STOPPER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. FACILITY CONTACT: XXXX XXXX. DEPARTMENT: MATERIALS MANAGEMENT. PHONE NUMBER: XXXX. EMAIL: XXXXX. PRODUCT CATALOG NUMBER:383560. PRODUCT DESCRIPTION: CATHETER IV 18GA 1.75IN STABILIZATION PLATFORM BD NEXIVA MAXZERO STERILE LATEX FREE DISPOSABLE. ORIGIN OF THE ISSUE: LABORATORY. DETAIL: PRODUCT QUALITY, LAKELAND WAREHOUSE, CATALOG NUMBER 383560, LOT NUMBER 4081120, COID (B)(4). THE PERSON PLACING THE IV PULLED THE NEEDLE OUT AND BLOOD LEAKED OUT OF THE GRAY RUBBER STOPPER. NUMBER OF OCCURRENCES: 1.0. ON (B)(6) 2025; THE DATE IS (B)(6) 2025. NO PATIENT HARM HAPPENED. THE IV WAS REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307290 BD NEXIVA SP WITH MAXZERO PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4081120 00382903835607

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown