BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT

    MDR report key: 19892937 · Received August 2, 2024

    Report

    Report Number
    1710034-2024-00815
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    July 9, 2024
    Report Date
    July 11, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF NEEDLE THROUGH CATHETER WITH LOT # 4029679 AND MATERIAL # 383511. NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383511 AND LOT NUMBER 4029679. 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. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA SINGLE PORT NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS PER ACCOUNT, WHEN THE NURSE TRIED TO CANULATE THE IV THE NEEDLE PASSED THROUGHOUT THE CANULA, THE PATIENT NEEDED TO HAVE THE IV REINSERTED. AS PER THE UNIT TEAM, IT'S NOT THE FIRST IT'S HAPPENING, MORE COMMON WITH NEXIVIA 24 GA. (B)(6). HOW WAS THE PATIENT OUTCOME? ANOTHER IV CATHETER WAS REINSERTED, NOT PLEASANT FOR THE PATIENT ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? DELAY OF CARE ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO THE PATIENT OR HEALTH CARE PROFESSIONAL? STRESSFUL PROCEDURE HAD TO BE REDONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863564 BD NEXIVA SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4029679

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown