BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD UNKNOW NEXIVA

    MDR report key: 20476107 · Received October 17, 2024

    Report

    Report Number
    9610847-2024-00311
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Date of Event
    August 29, 2024
    Report Date
    February 22, 2025
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE 12 UNOPENED SAMPLES, 3 OPENED SAMPLE AND 2 PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF NEEDLE THROUGH CATHETER WAS CONFIRMED UPON INSPECTION OF THE SAMPLES. ANALYSIS OF THE SAMPLE SHOWED THAT THE NEEDLE PIERCING THROUGH THE CATHETER TUBING NEAR THE NOSE OF THE ADAPTER. BD DETERMINED THAT THE CAUSE OF THE FAILURE WAS USER ERROR. THE REPORTED ISSUE OF NEEDLE DULL / BLUNT WAS NOT CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. ANALYSIS OF THE SAMPLE SHOWED THAT THE RESULTED IN ACCEPTABLE RESULTS FOR ALL SAMPLES WHEN PERFORMING PENETRATION AND DRAG TESTS. THE REPORTED ISSUE OF FLASHBACK (POOR / NO) WAS NOT CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. ANALYSIS OF THE SAMPLE SHOWED THAT ALL SAMPLES HAD PROPER FLOW AND DID NOT STOP HALFWAY. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD UNKNOWN NEXIVA CATHETER BROKE / SEPARATED AFTER PLACEMENT IT WAS REPORTED BY CUSTOMER THAT THE ALL THREE IVS WERE INITIATED INTO THE SKIN AND VESSEL WITH DIFFICULTY. IT WAS VERY HARD. ALMOST FEELS LIKE THE NEEDLES ARE NOT THAT SHARP. ONCE IN THE VESSEL, RETURN BLOOD FLOOD FLOW WAS PRESENT BUT STOPPED HALFWAY. THEY DID NOT COMPLETELY BACK FILL. WHEN FLUSHED ALL 3 IV'S BLOWN. AND ESSENTIALLY THE CATHETER HAD DISCONNECTED FROM THE NEEDLE AT THE BOTTOM. JUST WANTED TO MAKE YOU AWARE ABOUT THE ISSUE BECAUSE IT COULD CAUSE ISSUES OF PARTS OF THE CATHETER GETTING LEFT IN THE VEIN. ON (B)(6) 2024 : WE CURRENTLY HAD THREE ISSUES TODAY, (B)(6) 2024, WITH NEXIVA ISSUES. TWO WERE 20G NEXIVA LOT 4095643 REF (B)(4). ONE 22G NEXIVA LOT 4131782 REF. ALL THREE IVS WERE INITIATED INTO THE SKIN AND VESSEL WITH DIFFICULTY. IT WAS VERY HARD. ALMOST FEELS LIKE THE NEEDLES ARE NOT THAT SHARP. ONCE IN THE VESSEL, RETURN BLOOD FLOOD FLOW WAS PRESENT BUT STOPPED HALFWAY. THEY DID NOT COMPLETELY BACK FILL. WHEN FLUSHED ALL 3 IV'S BLOWN. ON (B)(6) 2024: ESSENTIALLY THE CATHETER HAD DISCONNECTED FROM THE NEEDLE AT THE BOTTOM. JUST WANTED TO MAKE YOU AWARE ABOUT THE ISSUE BECAUSE IT COULD CAUSE ISSUES OF PARTS OF THE CATHETER GETTING LEFT IN THE VEIN. WHEN WAS THIS DEFECT OBSERVED (WE ALSO HAD AN ISSUE RECENTLY WHERE IT APPEARS THE NEEDLE COMPLETELY PUNCTURED THROUGH THE CATHETER)? DURING OR BEFORE USE? IT APPEARS THIS WAS DURING USE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033319 BD UNKNOW NEXIVA INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown