BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA 22 GA X 1.00IN SP WITH MAXZERO

    MDR report key: 18461171 · Received January 6, 2024

    Report

    Report Number
    1710034-2023-01510
    Event Type
    Malfunction
    Date Received
    January 6, 2024
    Date of Event
    November 21, 2023
    Report Date
    March 12, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835523
    PMA / PMN Number
    K170336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: RECEIVED FOUR PHOTOGRAPHS IN AN EMAIL OF AN UNSEALED 22GA X 1.00IN. NEXIVA UNIT. AN ADDITIONAL FOUR PHOTOGRAPHS WERE PROVIDED BY THE COMPLAINANT. THE COMPLAINT THAT A PIECE OF PLASTIC BROKE OFF THE VENT PLUG WAS CONFIRMED FOR LOT #3096453. A SAMPLE FOR THE IMPLICATED LOT WAS RECEIVED FOR PR #9308315. THE PHOTOGRAPHS AND RETURNED SAMPLES FOR LOTS 3059798, 3059799, 3096453, 3234050, AND 3234689 EXHIBITED A SMALL SLIVER OF PLASTIC THAT SHEARED OFF THE EDGE OF THE VENT PLUG LUER TIP. EACH AFFECTED LOT WAS MANUFACTURED ON LINE 3. DURING MANUFACTURING, DAMAGE TO THE TIP OF THE VENT PLUG MAY OCCUR DUE TO INCORRECT PROCESSING PARAMETERS AND MISALIGNMENT BETWEEN THE VENT PLUG AND LUER ADAPTER. THE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT. INVESTIGATION CONCLUSION(S): THE COMPLAINT OF ¿FOREIGN MATTER - COMP FRAGMENTS/PLASTIC - VENT PLUG" WAS CONFIRMED FOR LOT #3096453. PROBABLE ROOT CAUSE(S): MANUFACTURING.

    Additional Manufacturer Narrative · 0

    E4. THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 21/11/2023 MEDWATCH REPORT IS MW5148485. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA WITH MAXZERO HAD FOREIGN MATTER INSIDE OF THE IV. IT WAS REPORTED VIA MEDWATCH "NURSE OBSERVED A SHARD OF PLASTIC BROKE OFF INTO THE HUB OF THE IV WHEN THE DISPOSABLE PLASTIC CAP/PLUG WAS REMOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675264 BD NEXIVA 22 GA X 1.00IN SP WITH MAXZERO PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3096453 30382903835523

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown