BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA

    MDR report key: 19995882 · Received August 15, 2024

    Report

    Report Number
    1710034-2024-00884
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    May 14, 2024
    Report Date
    August 12, 2024
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS A RESULT OF AN INVESTIGATION FINDING. THE COMPLAINT THAT THE NEEDLE WOULD NOT RELEASE FROM THE CATHETER ADAPTER WAS CONFIRMED AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. ONE 20G NEXIVA DEVICE FROM LOT #4030906 WAS PROVIDED FOR INVESTIGATION. THE TIP SHIELD SAFETY MECHANISM WOULD NOT SEPARATE FROM THE CATHETER ADAPTER BECAUSE THE V-CLIP COMPONENT WAS CAUGHT ON FLASH THAT WAS CREATED WHEN THE NEEDLE PUNCTURED THE TIP SHIELD DUE TO MISALIGNMENT DURING ASSEMBLY. THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. 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 NEEDLE DID NOT SEPARATED FROM HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN PUT IV IN, AND NEEDLE HUB WOULD NOT DISCONNECT FROM IV. IV HAD TO BE REMOVED FROM PATIENT AND STARTED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895455 BD NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4059660 00382903835362

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown