BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA 22 GA X 1 IN SINGLE PORT

    MDR report key: 19425696 · Received May 30, 2024

    Report

    Report Number
    1710034-2024-00507
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    May 7, 2024
    Report Date
    August 15, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835171
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. D. THE LOT NUMBER 3234046 PROVIDED CANNOT BE VERIFIED IN ASSOCIATION WITH THE REPORTED MATERIAL NUMBER.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED ONE PHOTOGRAPH OF A 20G NEXIVA DEVICE WITHOUT THE NEEDLE. WHAT APPEARED TO BE BLOOD RESIDUE WAS OBSERVED IN THE CATHETER TUBING, CATHETER ADAPTER, AND EXTENSION TUBING. IT APPEARED THAT BLOOD BYPASSED THE SEPTUM AND LEAKED FROM THE CATHETER ADAPTER. THE SEPTUM APPEARED TO BE DEFORMED AND SMEARED BETWEEN THE INNER WALL OF THE CATHETER ADAPTER AND THE CANNISTER. THE REPORTED NONCONFORMANCE HAS BEEN CONFIRMED. THIS WAS THE PHYSICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO A MISALIGNMENT IN THE AUTOMATED SEPTUM ASSEMBLY STATION. DURING MANUFACTURE, FUNCTIONAL TESTING FOR OCCLUSION AND LEAKAGE IS PERFORMED TO MITIGATE SUCH OCCURRENCES. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT OF A LEAK FROM THE CATHETER SEPTUM WAS CONFIRMED AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. ONE PHOTOGRAPH WAS PROVIDED FOR INVESTIGATION. THE PHOTO SHOWED A 20G NEXIVA UNIT WITH EVIDENCE OF USE. THE IMPLICATED PRODUCT FOR THIS COMPLAINT WAS A 22G NEXIVA DEVICE. THE NEEDLE AND TIP SHIELD SAFETY MECHANISM HAD BEEN REMOVED AND WERE NOT VISIBLE IN THE PHOTO. WHAT APPEARED TO BE BLOOD RESIDUE HAD BYPASSED THE SEPTUM. THE SEPTUM APPEARED TO BE SMEARED BETWEEN THE INNER WALL OF THE CATHETER ADAPTER AND THE CANNISTER, WHICH LIKELY OCCURRED DUE TO MISALIGNMENT DURING ASSEMBLY. THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA 22 GA X 1 IN SINGLE PORT LEAKED AT THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN PLACED AN IV, AND WHEN THE SAFETY NEEDLE WAS RETRACTED, THE IV LEAKED BLOOD FROM THE AREA WHERE THE NEEDLE WAS RETRACTED.

    Description of Event or Problem · 0

    THE CUSTOMER CONFIRMED SHE WAS ONLY SUPPLIED A BATCH NUMBER SO THE MATERIAL AND BATCH INFORMATION WERE UPDATED TO REFLECT THE INFORMATION PRESENT IN THE SAMPLE PHOTO.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1423441 BD NEXIVA 22 GA X 1 IN SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3234046 00382903835171

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown