BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA NEARPORT 20GA X 1.00IN W/ MAXZERO

    MDR report key: 21143075 · Received January 13, 2025

    Report

    Report Number
    9610847-2024-00411
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Date of Event
    December 23, 2024
    Report Date
    February 19, 2025
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    00382903935260
    PMA / PMN Number
    K231239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF PRODUCT MALFUNCTION DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, 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 NEARPORT 20GA X 1.00IN W/ MAXZERO NEEDLE RETRACTION FAILED. IT WAS REPORTED BY CUSTOMER THAT OUR STAFF BROUGHT FORTH TWO EXAMPLES WHEN THE NEEDLE DID NOT FULLY RETRACT FROM A 20G NEXIVA IN THE EC. BELOW IS THE LOT NUMBER/INFORMATION FROM ONE OF PACKAGES. (B)(4). EXPIRES 2027-08-31, LOT: 4247493, 2024-09-06. OUR STAFF BROUGHT FORTH TWO EXAMPLES WHEN THE NEEDLE DID NOT FULLY RETRACT FROM A 20G NEXIVA IN THE EC. BELOW IS THE LOT NUMBER/INFORMATION FROM ONE OF PACKAGES. (B)(4). EXPIRES 2027-08-31, LOT: 4247493, 2024-09-06.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2211718 BD NEXIVA NEARPORT 20GA X 1.00IN W/ MAXZERO INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN 00382903935260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown