BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SP WITH MAXZERO

    MDR report key: 20541445 · Received October 27, 2024

    Report

    Report Number
    1710034-2024-01212
    Event Type
    Malfunction
    Date Received
    October 27, 2024
    Date of Event
    August 9, 2024
    Report Date
    December 10, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835577
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383557 AND LOT NUMBER 4152107. 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.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO DIFFICULTY DISENGAGING THE NEEDLE RESULTING IN PIERCING THE CATHETER AND LEAKAGE OF BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE IS SUPER DIFFICULT TO RETRACT AND WILL ACTUALLY GRIND WHILE FORCING A RETRACTION. IN SOME INSTANCES, THE FORCE THAT HAS HAD TO BE USED TO RETRACT THE NEEDLE HAS CAUSED A PUNCTURE IN THE TUBING WHICH THEN LEAKS AND WE HAVE TO RE-STICK THE PATIENT. INJURIES OR ADVERSE EVENT: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2026609 BD NEXIVA SP WITH MAXZERO PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4152107 00382903835577

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown