BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT

    MDR report key: 19344213 · Received May 17, 2024

    Report

    Report Number
    1710034-2024-00453
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Date of Event
    April 22, 2024
    Report Date
    June 7, 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
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. STREET ADDRESS INFORMATION CHARACTER LIMIT IS EXCEEDED: (B)(6). 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: RECEIVED 3 UNSEALED 20GA X 1.25IN. NEXIVA UNITS FROM LOT: 3234046. ADDITIONALLY, 5 PHOTOS WERE PROVIDED. VISUAL INSPECTION DISCOVERED THERE WAS SOME MEDIA ON THE BOTTOM OF THE CANISTER. THIS IS NORMALLY A RESULT OF SEPTUM OR CANISTER DAMAGE. MICROSCOPIC ANALYSIS CONFIRMED THERE WERE GAPS BETWEEN THE SEPTUM AND THE CANISTER. THE REPORTED DEFECT WAS CONFIRMED. DURING MANUFACTURING THIS DEFECT MAY OCCUR. DURING ASSEMBLING THE SECONDARY SEPTUM IN THE CANISTER, IT IS POSSIBLE FOR THE SEPTUM TO NOT BE FULLY SEATED, OR DAMAGE DUE TO MACHINE MISALIGNMENT. THIS MAY CAUSE LEAKAGE DURING USE. AN EQUIPMENT DESIGN OF PLACING PARTS ASSURE ORIENTATION AND ALIGNMENT TO MITIGATE THE OCCURRENCE OF THIS DEFECT. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. INVESTIGATION CONCLUSION(S): THE DEFECT OF ¿LEAKAGE AT SEPTUM¿ WAS CONFIRMED. PROBABLE ROOT CAUSE(S): MANUFACTURING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA SINGLE PORT LEAKED AT THE SEPTUM THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: IN THE CT ROOM, AFTER THE PUNCTURE WAS SUCCESSFUL, THE ISOLATION PLUG LEAKED BLOOD WHEN THE STEEL NEEDLE WAS PULLED OUT. A CLAIM NEEDS TO BE SETTLED, A COMPLAINT REPLY LETTER IS REQUIRED, AND A COMPLAINT ACCEPTANCE LETTER IS REQUIRED. THE SAMPLE CAN BE RETURNED BUT THERE IS BLOOD, AND PHOTOS ARE PROVIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743450 BD NEXIVA SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3234046 00382903835171

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown