BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA DIFFUSICS

    MDR report key: 24444430 · Received February 25, 2026

    Report

    Report Number
    9610847-2026-00073
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    February 8, 2026
    Report Date
    April 14, 2026
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    00382903835935
    PMA / PMN Number
    K173354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE 3 PHOTOS AND 1 PHYSICAL SAMPLE SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF CATHETER BROKE / SEPARATED AFTER PLACEMENT WAS CONFIRMED UPON INSPECTION OF THE SAMPLES. ANALYSIS OF THE SAMPLE SHOWED THAT THE REPORTED DEFECT WAS OBSERVED. BD DETERMINED THAT THE CAUSE OF THE FAILURE WAS LACK OF CURING OF BONDING ADHESIVE AND INCORRECT OR NON-APPLICATION OF TEST TO CONFIRM SECURE BOND. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    MATERIAL # 383593 BATCH #5182130. IT WAS REPORTED BY CUSTOMER THAT IV CATHETER SNAPPED AT THE CONNECTION OF THE TUBING TO THE HUB WHILE INSERTING THE CATHETER INTO THE PATIENT. THE IV SEPARATED AT THIS CONNECTION. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. (B)(6) REFERENCE NUMBER (ID): DATE OF INCIDENT (YYYY-MM-DD): 2026-02-08 TYPE OF INCIDENT/PROBLEM: A2. FAILURE (I.E. WHILE PREPARING FOR, IN USE, AFTER USE) LEVEL OF HARM: MODERATE HARM (B)(6) OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): INCIDENT DETAILS: IV CATHETER SNAPPED AT THE CONNECTION OF THE TUBING TO THE HUB WHILE INSERTING THE CATHETER INTO THE PATIENT. THE IV SEPARATED AT THIS CONNECTION. IMPACT OF INCIDENT: ["HAD TO REMOVE IV AND RE-INSERT A NEW IV IN A DIFFERENT LOCATION. BLOOD EXPOSURE AT THE SITE OF THE DISCONNECTION POTENTIAL FOR EXPOSURE. "] WHO WAS AFFECTED? PATIENT UNEXPECTED OR PROLONGED CARE? YES FREQUENCY OF PROBLEM: FIRST TIME OTHER DEVICE/INCIDENT FACTORS: INVASIVE PROCEDURE? YES PROCEDURE: IV INSERTION PHYSICIAN: UNSURE DEVICE INFORMATION DEVICE NAME/DESCRIPTION: CATHETER IV PASSIVE SAFETY NON-WINGED CLOSED SYSTEM PINK 20GAX31.75MM NEXIVA DIFFUSICS MANUFACTURER: MANUFACTURER CODE/MODEL: 383593 SERIAL OR LOT NUMBER: (B)(6) EXPIRY DATE: 2028-06-30 SUPPLIER: SUPPLIER/CATALOGUE NUMBER: IS THE DEVICE RETAINED? YES NUMBER OF DEVICES: WIPED, CONTAINED, LABELLED? DEVICE HANDLING HAZARDS (WHEN BLANK = HAZARDS NOT SPECIFIED) INVESTIGATION REQUEST EXPECTED TYPE OF INVESTIGATION: ACTUAL DEVICE TESTED; LOT REVIEW; REPORT HISTORY/TREND ANALYSIS; SHIPPING INSTRUCTIONS REQUEST DATE (YYYY-MM-DD): 2026-02-11 E-MAIL ADDRESS FOR PERSON HOLDING DEVICE: SITE SHIPPING ADDRESS:

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274930 NEXIVA DIFFUSICS INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 5182130 00382903835935

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown