BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CATHETER IV PASSIVE SAFETY NON-WINGED CLOSED SYSTEM SINGE PORT NEXIVA

    MDR report key: 19408970 · Received May 28, 2024

    Report

    Report Number
    1710034-2024-00499
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    May 1, 2024
    Report Date
    July 31, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH AND SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE PHOTO AND ONE USED 20G X 1.25IN. NEXIVA UNIT FROM LOT NUMBER 3234047. 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. UPON FURTHER INSPECTION UNDER A MICROSCOPE, IT WAS FOUND THAT THE PRIMARY SEPTUM WAS POSITIONED INCORRECTLY ON THE CANISTER, CAUSING A PORTION OF IT TO BE SMEARED ON ONE SIDE BETWEEN THE CANISTER AND THE WALL OF THE CATHETER ADAPTER. GIVEN THE POSITIONING OF THE PRIMARY SEPTUM, IT IS LIKELY THAT THE SEPTUM DID NOT CREATE FULL SEAL AND ALLOWED FLUID TO LEAK PAST IT. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO A MISALIGNMENT. MISALIGNMENT OR DAMAGE TO THE INSERTION STATION/VACUUM PROBE COULD CAUSE DAMAGE TO THE PRIMARY SEPTUM AND CANISTER. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CATHETER IV PASSIVE SAFETY NON-WINGED CLOSED SYSTEM SINGE PORT PINK 20GX31.75MM NEXIVA- CATHETER LEAKED BEYOND THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON INTRAVENOUS ATTEMPT ON PATIENT, 20G NEXIVA IV INITIATED. WHEN NURSE ATTEMPTED TO FLUSH THE NEXIVA WITH NS THE FLUSH SOLUTION LEAKED OUT OF THE PORT WHERE THE NEEDLE IS REMOVED FROM. CAUSING THE IV TO HAVE TO BE REMOVED AND RESITED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328873 BD CATHETER IV PASSIVE SAFETY NON-WINGED CLOSED SYSTEM SINGE PORT NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3234047

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown