BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA 20GA 1.25IN HF Y

    MDR report key: 21964763 · Received May 5, 2025

    Report

    Report Number
    1710034-2025-00744
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    January 13, 2025
    Report Date
    July 14, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835379
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383537 AND LOT NUMBER 4212093, 4156923. 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

    THE COMPLAINT OF A DAMAGED ADAPTER WAS CONFIRMED, AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. ONE 20G NEXIVA DEVICE WAS RETURNED FOR INVESTIGATION WITH OPEN PACKAGING FOR LOTS 4212093 AND 4156923. IT COULD NOT BE DETERMINED WHICH LOT WAS ASSOCIATED WITH THE RETURNED SAMPLE. THE SAMPLE EXHIBITED EVIDENCE OF USE. THE THREADED REGION OF THE PINK DUAL PORT ADAPTER EXHIBITED DEFORMATION THAT WAS CONSISTENT WITH THE ASSEMBLY PROCESS. THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    Description of Event or Problem · 0

    EVENT DETAILS: MATERIAL # 383537, BATCH #4212093, 4156923. IT WAS REPORTED BY THE CUSTOMER THAT THE PRODUCT CRACKED AT HUB. STARTED THE IV AND THEN IT LEAKED EVERYWHERE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DATE OF INCIDENT: (B)(6) 2025. DEPARTMENT: OR. PRODUCT: BD NEXIVA 20 G. VMID: 383537. LOT NUMBER: 4212093, 4156923. PRODUCT EXPIRY DATE: 31-MAY-2027. NUMBER OF DEFECTIVE PRODUCT(S): 1. IS SAMPLE AVAILABLE: YES. CONCERN DESCRIPTION: CRACKED AT HUB. STARTED THE IV AND THEN IT LEAKED EVERYWHERE AND PT HAD TO GET STABBED TWICE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73654 NEXIVA 20GA 1.25IN HF Y CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4212093 00382903835379

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown