BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SP WITH MAXZERO

    MDR report key: 20541345 · Received October 27, 2024

    Report

    Report Number
    1710034-2024-01211
    Event Type
    Malfunction
    Date Received
    October 27, 2024
    Date of Event
    October 3, 2024
    Report Date
    December 2, 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

    A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT THAT THE NEEDLE WAS DIFFICULT TO WITHDRAW THROUGH THE IV CATHETER AND TIP SHIELD WAS CONFIRMED AND THE CAUSE APPEARED TO BE SUPPLIER RELATED. REPRESENTATIVE 20G NEXIVA UNITS FROM LOT# 4152107 WERE PROVIDED FOR INVESTIGATION. TWO SAMPLES WERE FOUND WITH RESISTANCE BETWEEN THE NEEDLE AND SAFETY MECHANISM. A GRINDING OR SCRAPING NOISE ACCOMPANIED THE RESISTANCE. THE OUTSIDE DIAMETER OF EACH NEEDLE WAS WITHIN SPEC; HOWEVER, THE INSIDE DIAMETER OF THE WASHER IN THE SAFETY MECHANISM WAS BELOW SPECIFICATION, WHICH CREATED FRICTION AS THE NEEDLE WITHDRAWN THROUGH THE SAFETY MECHANISM. THE ROOT CAUSE OF THE REPORTED ISSUE WAS LIKELY SUPPLIER RELATED. THE APPROPRIATE PERSONNEL WERE NOTIFIED OF THIS COMPLAINT. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA SP WITH MAXZERO NEEDLE DISENGAGEMENT DIFFICULTIES RESULTED IN NEEDLE PIERCING THE CATHETER AND BLOOD LEAK. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047807 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