BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA 20GA 1.00IN HF Y

    MDR report key: 11780969 · Received May 5, 2021

    Report

    Report Number
    1710034-2021-00375
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    April 8, 2021
    Report Date
    May 19, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835362
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEXIVA 20GA 1.00IN HF Y NEEDLE WAS PARTIALLY DISENGAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383536 BATCH NO: 1011021. IT WAS REPORTED THAT AN ULTRASOUND WAS USED TO PLACE IV CATHETER. IV WAS INSERTED AND NEEDLE WAS PULLED BACK TO REMOVE, BUT WOULD NOT DETACH FROM THE CLOSED SYSTEM.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEXIVA 20GA 1.00IN HF Y NEEDLE WAS PARTIALLY DISENGAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383536, BATCH NO: 1011021. IT WAS REPORTED THAT AN ULTRASOUND WAS USED TO PLACE IV CATHETER. IV WAS INSERTED AND NEEDLE WAS PULLED BACK TO REMOVE, BUT WOULD NOT DETACH FROM THE CLOSED SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674689 NEXIVA 20GA 1.00IN HF Y CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 1011021 00382903835362

    Patients

    Seq Age Sex Outcome Treatment
    1 13 DA