BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD NEXIVA DUAL PORT WITH Q-SYTE, 24G X 0.75"

    MDR report key: 15929541 · Received December 6, 2022

    Report

    Report Number
    1710034-2022-00757
    Event Type
    Injury
    Date Received
    December 6, 2022
    Date of Event
    September 26, 2022
    Report Date
    January 3, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835318
    PMA / PMN Number
    K102520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORTER ALSO NOTIFIED THE FDA. MEDWATCH REPORT:# (B)(4). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS EVENT BUT WITHOUT A SAMPLE NO CORRECTIVE ACTIONS COULD BE IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NEXIVA DUAL PORT WITH Q-SYTE, 24G X 0.75" RAPID INFILTRATION REQUIRED AN ULTRASOUND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING A SURGICAL HYSTEROSCOPY THE MYOSURE WAS INFILTRATING THE SALINE VERY RAPIDLY. THE SURGEON PAUSED THE PROCEDURE, AND THE REP WAS CALLED FOR GUIDANCE. AFTER SPEAKING TO HIM THE DOCTOR STOPPED THE PROCEDURE AS THE FUNDUS WAS PERFORATED. THE SURGEON USED ULTRASOUND AT THE END OF THE PROCEDURE TO VERIFY IF EXCESS FLUID WAS IN THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NEXIVA DUAL PORT WITH Q-SYTE, 24G X 0.75" RAPID INFILTRATION REQUIRED AN ULTRASOUND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING A SURGICAL HYSTEROSCOPY THE MYOSURE WAS INFILTRATING THE SALINE VERY RAPIDLY. THE SURGEON PAUSED THE PROCEDURE, AND THE REP WAS CALLED FOR GUIDANCE. AFTER SPEAKING TO HIM THE DOCTOR STOPPED THE PROCEDURE AS THE FUNDUS WAS PERFORATED. THE SURGEON USED ULTRASOUND AT THE END OF THE PROCEDURE TO VERIFY IF EXCESS FLUID WAS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2508268 BD NEXIVA DUAL PORT WITH Q-SYTE, 24G X 0.75" INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383531 UNKNOWN 30382903835318

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown