BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 17825262 · Received September 27, 2023

    Report

    Report Number
    1710034-2023-01112
    Event Type
    Malfunction
    Date Received
    September 27, 2023
    Date of Event
    August 30, 2023
    Report Date
    November 7, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K102520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PHOTOGRAPHS SHOWED WHAT APPEARED TO BE AN UNUSED 20G NEXIVA DEVICE AND A SEPARATE NEEDLE THAT HAD BEEN RETRACTED THROUGH THE TIP SHIELD SAFETY MECHANISM. DIFFICULTY WITH NEEDLE DISENGAGEMENT CAN OCCUR DUE TO A DAMAGED COMPONENT. NO DAMAGE OR MANUFACTURING DEFECTS WERE NOTED ON EITHER OF THE SAMPLES SHOWN IN THE PHOTOS. AS THE SAMPLES INVOLVED IN THIS INCIDENT WERE NOT AVAILABLE FOR INVESTIGATION, A FUNCTIONAL TEST COULD NOT BE COMPLETED TO VERIFY THE REPORTED ISSUE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOTS 3087439 AND 3150412, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THIS ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. BASED ON THE AVAILABLE INFORMATION, WE CANNOT IDENTIFY A DEFINITIVE ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. ADDITIONAL LOT NUMBER WAS REPORTED. THE REPORTED LOT NUMBER IS [3150412] , HOWEVER, THIS IS NOT A LOT # MANUFACTURED FOR THE REPORTED CATALOG #[383536]. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE DISENGAGEMENT ON THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WAS DIFFICULT. (EVENT 1 OF 3). THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CUSTOMER STATED THAT THE NEEDLES ARE NOT RETRACTING AND NURSES ARE HAVING A HARD TIME REMOVING THEM FROM PATIENTS AFTER ADMINISTERING MEDS. TWO DIFFERENT LOTS, BUT IT IS UNKNOWN AS TO HOW MANY INSTANCES THEY HAVE HAD. NO DEFINITIVE DATE OF EVENT. 10 OCT 23 I HAVE VERIFIED THE LOT NUMBER AND THE 2 EFFECTED LOTS ARE 3150142 AND 3087439. BELOW IS ADDITIONAL INFORMATION THAT WAS OBTAINED DURING 3 DIFFERENT DATES: 8/30/23, 9/5/23, 9/7/23 THE PEN IS POINTING TO AN INTERNAL METAL PIECE IN THE DEVICE THAT SHOULD SLIDE UP AND ALLOW THE NEEDLE TO BE REMOVED, HOWEVER IT APPEARS TO BE GETTING STUCK. THE BELOW IMAGE SHOWS: TOP WORKED CORRECTLY, THE INTERNAL METAL PIECE SLID UP AND ALLOWED THE NEEDLE TO BE REMOVED. BOTTOM DEFECTIVE, GOT STUCK, THE METAL PIECE WILL NOT SLIDE UP, APPEARS TO GET STUCK ON A LIP AND PREVENT REMOVAL. FIRST REPORT (8/21/23, (B)(4): LOT #3087439.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE DISENGAGEMENT ON THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WAS DIFFICULT. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CUSTOMER STATED THAT THE NEEDLES ARE NOT RETRACTING AND NURSES ARE HAVING A HARD TIME REMOVING THEM FROM PATIENTS AFTER ADMINISTERING MEDS. TWO DIFFERENT LOTS, BUT IT IS UNKNOWN AS TO HOW MANY INSTANCES THEY HAVE HAD. NO DEFINITIVE DATE OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831609 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3087439 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown