BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT

    MDR report key: 20045221 · Received August 23, 2024

    Report

    Report Number
    1710034-2024-00921
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 19, 2024
    Report Date
    August 29, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835164
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383516 AND LOT NUMBER 3072356. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA SINGLE PORT HUB CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ¿THE PATIENT UNDERWENT A CARDIAC CORONARY EXAMINATION, THE INDWELLING NEEDLE WAS NORMALLY CONNECTED TO THE HIGH PRESSURE SYRINGE INTERFACE, THE WATER TEST WAS NORMAL, AND WHEN THE HIGH PRESSURE INJECTION WAS ADMINISTERED, THE INDWELLING NEEDLE CONNECTION CRACKED AND DID NOT FUNCTION PROPERLY, RESULTING IN EXTRAVASATION OF THE CONTRAST AGENT, AND THE PATIENT'S BLOOD FLOWED BACK OUT OF THE CATHETER, AND THE EXAMINATION FAILED. SUBSEQUENTLY, THE CATHETER WAS REPOSITIONED AND THE EXAMINATION WAS SUCCESSFUL¿

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2072128 BD NEXIVA SINGLE PORT PERIPHERAL IV CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3072356 00382903835164

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown