BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA NEARPORT 20GA X 1.00IN W/ MAXZERO

    MDR report key: 20904635 · Received December 11, 2024

    Report

    Report Number
    1710034-2024-01475
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    May 28, 2024
    Report Date
    January 22, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903935260
    PMA / PMN Number
    K231239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 393526 AND LOT NUMBER 4032624. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. 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

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Description of Event or Problem · 0

    MATERIAL # 393526. BATCH # 4032624. INSERTED BD NEXIVA CLOSED IV CATHETER SYSTEM WITH NEARPORT IV ACCESS, THE LINE FLUSHED SEVERAL TIMES. REGISTERED NURSE (RN) HUNG IV FLUIDS, AND THE LINE WOULD NOT FLUSH. RN CHECKED THE NEXIVA AND THE CATHETER WAS BENT. RN TOLD THIS NURSE THIS HAS HAPPENED SEVERAL TIMES WITH THE NEW NEXIVA IVS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2436707 NEXIVA NEARPORT 20GA X 1.00IN W/ MAXZERO CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON 4032624 00382903935260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female