BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA 20GA 1.00IN HF Y

    MDR report key: 18085958 · Received November 7, 2023

    Report

    Report Number
    1710034-2023-01261
    Event Type
    Malfunction
    Date Received
    November 7, 2023
    Date of Event
    October 8, 2023
    Report Date
    December 12, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K102520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED TWO PHOTOGRAPHS WHICH DISPLAYED A 20G NEXIVA DEVICE IN A PLASTIC BAG FROM REFERENCE NUMBER (B)(4), LOT NUMBER 3011703. THE DEVICE EXHIBITED EVIDENCE OF USE. THE NEEDLE HAD BEEN REMOVED FROM THE CATHETER ADAPTER AND TAPE WAS WRAPPED AROUND THE EXTENSION TUBING. WHAT APPEARED TO BE BLOOD RESIDUE WAS OBSERVED WITHIN THE CATHETER TUBING. NO BLOOD COULD BE SEEN AT OR AROUND THE SEPTUM WITHIN THE CATHETER ADAPTER. THE REPORTED ISSUE MAY OCCUR IF THE SEPTUM AND CANISTER ARE DAMAGED OR MISALIGNED; HOWEVER, NO DAMAGE OR DEFECTS COULD BE CONFIRMED FROM THE PHOTOGRAPHS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED: DATE OF EVENT: 08OCT202.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA 20GA 1.00IN HF Y LEAKED AT THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON COMPLETION OF ESTABLISHING AN IV, WITH THE NEXIVA 20G X 1IN. HF DUAL CATHETER, BLOOD LEAKED OUT OF THE GRAY IN-LINE PORT LOCATED ON THE BACK OF THE 20G CATHETER. I BELIEVE THE PROBABLE CAUSE WAS A DEFECT IN THE PRODUCT. THE IV WAS TERMINATED AND A NEW IV WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208783 NEXIVA 20GA 1.00IN HF Y PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3011703 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown