BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD CONNECTA PLUS3 WHITE

    MDR report key: 23996360 · Received January 7, 2026

    Report

    Report Number
    9610847-2025-00490
    Event Type
    Injury
    Date Received
    January 7, 2026
    Date of Event
    October 4, 2025
    Report Date
    January 11, 2026
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: 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 NUMBER WAS MADE AVAILABLE FOR THIS REPORTED EVENT. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS NO BATCH/LOT NUMBER WAS MADE AVAILABLE FOR THIS REPORTED EVENT. THERE ARE PROPER CONTROLS IN PLACE TO DETECT PRODUCT MALFUNCTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONNECTA PLUS3 WHITE DISCONNECTED REFERENCE: LL 394600 BATCH NUMBER: BATCH 5126874 ? BATCH 5090988 ? BATCH 5094460 ? DATE OF OCCURRENCE: (B)(6) 2025 IT WAS REPORTED THAT "MISALIGNMENT OF A PLUG IN A CENTRAL VEIN LEADING TO BLEEDING AND CEREBRAL GAS EMBOLISM WITH MULTIFOCAL STROKE; LEFT HEMIPLEGIA AND PARESIS OF THE RIGHT HAND. NO BATCH IDENTIFIED AT THE TIME OF THE EVENT. THE BATCHES CURRENTLY PRESENT AT THE PUI ARE AS FOLLOWS: - BATCH: 5126874 EXP: 30/04/2028 - BATCH: 5090988 EXP: 29/02/2028 - BATCH: 5094460 EXP: 31/03/2028 CURRENT PATIENT STATUS: PROBABLE PERMANENT FUNCTIONAL DEFICIT ACTIONS TAKEN IN THE HEALTHCARE FACILITY TO TREAT THE PATIENT: VVC LAMPING TRANSFER TO THE INTENSIVE CARE UNIT BRAIN IMAGING PERFORMED: CT AND MRI."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49807 BD CONNECTA PLUS3 WHITE INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other