BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA NEAR PORT

    MDR report key: 24259550 · Received February 4, 2026

    Report

    Report Number
    9610847-2026-00045
    Event Type
    Malfunction
    Date Received
    February 4, 2026
    Date of Event
    January 20, 2026
    Report Date
    February 27, 2026
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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

    CORRECTION: (B.3.) DATE OF EVENT WAS NOT PROVIDED; BD AWARENESS DATE HAS BEEN ENTERED IN THIS FIELD. INVESTIGATION RESULTS: THE REPORTED DEFECT COULD NOT BE REFUTED NOR CONFIRMED IN THE ABSENCE OF A SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED FOR AN UNCONFIRMED DEFECT. A COMPLAINT HISTORY (CHR) REVIEW COULD NOT BE PERFORMED AS NO BATCH/LOT AND MATERIAL NUMBER WAS MADE AVAILABLE FOR THIS REPORTED EVENT. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS NO BATCH/LOT AND MATERIAL NUMBER WAS MADE AVAILABLE FOR THIS REPORTED EVENT. A REVIEW OF THE APPLICABLE RISK DOCUMENT INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA NEAR PORT TUBING WAS DEFECTIVE / DAMAGED IT WAS REPORTED BY CUSTOMER THAT THE AVIA VASCULAR ALLY DEVICE WITH NEXIVA NEAR PORT CATHETER. DURING THE TRIAL IT APPEARS THAT THE ALLY DEVICE PUNCTURED THE NEARPORT SEPTUM OR TUBING DURING A DRAW. POST DRAW MEDICATION (ADENOSINE) THROUGH EXTENSION TUBING THEN RESULTED IN NURSE BEING 'SPRAYED'. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PER PRELIMINARY DISCUSSION WITH LOCAL TM - (B)(6) REGIONAL WAS TRIALING THE AVIA VASCULAR ALLY DEVICE WITH NEXIVA NEARPORT CATHETER. DURING THE TRIAL IT APPEARS THAT THE ALLY DEVICE PUNCTURED THE NEARPORT SEPTUM OR TUBING DURING A DRAW. POST DRAW MEDICATION (ADENOSINE) THROUGH EXTENSION TUBING THEN RESULTED IN NURSE BEING 'SPRAYED'.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320609 BD NEXIVA NEAR PORT INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown