BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA

    MDR report key: 19397590 · Received May 24, 2024

    Report

    Report Number
    1710034-2024-00493
    Event Type
    Malfunction
    Date Received
    May 24, 2024
    Date of Event
    May 2, 2024
    Report Date
    June 24, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835386
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: NO PHOTOGRAPHIC EVIDENCE OR PHYSICAL SAMPLES WERE ACCESSIBLE TO INVESTIGATE THE REPORTED CONDITION. OUR QUALITY ENGINEER TEAM CONDUCTED A COMPREHENSIVE REVIEW OF THE DEVICE HISTORY RECORD FOR THE PROVIDED MATERIAL NUMBER 383538 AND LOT NUMBER 3241214. THIS REVIEW DID NOT UNCOVER ANY ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CAUSED THIS DEFECT, AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN THE SPECIFIED STANDARDS. UNFORTUNATELY, THE EXACT CAUSE OF THIS INCIDENT COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. WE WILL CONTINUE TO TRACK AND ANALYZE COMPLAINTS RELATED TO THIS DEVICE AND THE REPORTED CONDITION IN ORDER TO IDENTIFY ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED REGARDING PATIENT. E/F CODES UPDATED.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    "HAS THERE BEEN ANY IMPACT ON THE PATIENT (SERIOUS INJURY, MEDICAL INTERVENTION, CHANGE OF TREATMENT REQUIRED)? = YES, PATIENT HAD TO BE RE-PRICKED, IS A PATIENT WHO IS DIFFICULT TO PRICK."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA LEAKED AT A CONNECTION THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE IV NEEDLE LEAKED TO THE DOUBLE LUMEN DURING THE INJECTION OF THE PATIENT AT THE CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2321820 BD NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3241214 00382903835386

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown