BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT

    MDR report key: 21278488 · Received January 30, 2025

    Report

    Report Number
    1710034-2025-00100
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    January 15, 2025
    Report Date
    March 11, 2025
    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
    PA, US
    Reporter Occupation
    NURSE
    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. D. TWO POTENTIAL LOT NUMBERS PROVIDED, BUT CUSTOMER DOES NOT KNOW WHICH ONE HAD THE REPORTED ISSUE: 4212433 OR 4242251.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383512 AND LOT NUMBERS 4242251 & 4212433. 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, CUSTOMER HAS NOT CONFIRMED ACTUAL THE LOT #. BASED ON FOLLOW UP ATTEMPT WERE MADE TO CONFIRM THE REPORTED LOT NUMBER WHICH WERE UNSUCCESSFUL. BASED ON THE INFORMATION PROVIDED WE DID PERFORM A DHR FOR BOTH LOT #PROVIDED WHICH CORRESPONDS TO MATERIAL 383512, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA SINGLE PORT TUBING SEPARATED FROM HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD NEXIA CLOSED IV CATHETER SYSTEM-SINGLE PORT, 22 GAUGE IV NEEDLE. # 383512. THE TUBING OFF TO THE SIDE DISCONNECTED FROM THE MAIN IV AND WAS NOT ABLE TO BE RECONNECTED. UNSURE WHICH LOT NUMBER DUE TO HAVING 2 PACKAGES OPEN. EITHER LOT # 4242251, EXP DATE 08/31/2027 OR 4212433, EXP DATE 07/31/2027. EVENT: "IV WAS STARTED, THE SMALL TUBE ON THE SIDE OF THE IV FELL OFF. THE IV HAD TO BE REMOVED AND RESTARTED. UNSURE WHICH LOT NUMBER DUE TO HAVING 2 DIFFERENT IV OPEN SINCE THIS WAS THE SECOND IV STICK. LOT NUMBERS: 4212433 OR 4242251. PATIENT WAS THEN STUCK 2 ADDITIONAL TIMES TO OBTAIN IV ACCESS. 27 JAN 2025 THERE WAS NO HARM TO A HEALTHCARE PROFESSIONAL OR THE PATIENT. THE LOT NUMBER WAS EITHER 4212433 OR 4242251. I HAD 2 DIFFERENT IV PACKAGES OPEN, SO I AM UNSURE WHICH LOT NUMBER IT WAS FOR CERTAIN. I DO NOT HAVE ANY PICTURES OF THE PRODUCT BECAUSE IT WAS CONTAMINATED WITH BLOOD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495118 BD NEXIVA SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903835126

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown