BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT

    MDR report key: 19323709 · Received May 15, 2024

    Report

    Report Number
    1710034-2024-00442
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Date of Event
    April 16, 2024
    Report Date
    July 10, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835126
    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

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED 13 UNSEALED 22GA X 1.00IN. NEXIVA UNIT FROM LOT: 3180979. ADDITIONALLY, 4 PHOTOS WERE PROVIDED. ONE OF THE PROVIDED PHOTOS DISPLAYED A CLINICIAN HOLDING A DEVICE WITH THE CATHETER TUBING CIRCLED JUST ABOVE THE NOSE OF THE ADAPTER. THE PHOTO SHOWED THE NEEDLE DISENGAGED AND WHAT APPEARED TO BE SOME BLOOD RESIDUE ON THE CATHETER NEAR THE NOSE OF THE CATHETER ADAPTER, BUT IT IS UNCLEAR IF THE CATHETER WAS PUNCTURED OR WHEN/HOW THE DAMAGE OCCURRED. BASED ON THE CIRCUMSTANTIAL EVIDENCE OF BLOOD RESIDUE ON THE CATHETER, THE REPORTED DEFECT WAS CONFIRMED. A VISUAL INSPECTION AND A LEAK TEST WERE PERFORMED WITH THE RETURNED SAMPLES, BUT NO DAMAGE WAS DISCOVERED. THE REPORTED NONCONFORMANCE HAS BEEN CONFIRMED. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    E. ADDRESS CHARACTER LIMIT IS EXCEEDED: (B)(6). E. FACILITY NAME CHARACTER LIMIT IS EXCEEDED: (B)(6) HOSPITAL H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    ADDITIONAL CUSTOMER RESPONSE: THE CATHETER BROKE AT THE END OF THE STEEL NEEDLE, WHICH DID NOT HAVE A SERIOUS EFFECT ON THE PATIENT'S BODY. THE FRAGMENTS HAVE NOT BEEN COMPLETELY SEPARATED, BUT HAVE CAUSED BLOOD EXPOSURE. THE QUALITY OF THE PRODUCT WAS QUESTIONED DUE TO THE PATIENT'S VISIBLE FRACTURE OF THE END OF THE STEEL NEEDLE, AS WELL AS THE VISIBLE BURRS AND UNEVEN PORTS AT THE END CAP. THE PATIENT COMPLAINED TO THE HOSPITAL AND ASKED THE HOSPITAL TO CONDUCT AN IN-DEPTH INVESTIGATION OF THE PRODUCT. AT PRESENT, THE HOSPITAL HAS STOPPED USING ALL THE PRODUCTS, AND ASKED OUR COMPANY TO CONDUCT QUALITY INSPECTION FOR THE PROBLEMATIC PRODUCTS AND GIVE A CORRESPONDING REPLY LETTER, THANK YOU.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA SINGLE PORT CATHETER HAS A HOLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: AFTER THE INDWELLING NEEDLE WAS SUCCESSFULLY PUNCTURED, THE CATHETER WAS FOUND TO BE BROKEN AT THE END OF THE STEEL NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520387 BD NEXIVA SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3180979 00382903835126

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown