BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.00 IN

    MDR report key: 17966487 · Received October 19, 2023

    Report

    Report Number
    1710034-2023-01207
    Event Type
    Malfunction
    Date Received
    October 19, 2023
    Date of Event
    September 7, 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
    OTHER HEALTH CARE PROFESSIONAL
    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 THE PHOTOGRAPHS SHOWED WHAT APPEARED TO BE AN UNUSED 20G NEXIVA DEVICE AND A SEPARATE NEEDLE THAT HAD BEEN RETRACTED THROUGH THE TIP SHIELD SAFETY MECHANISM.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

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, 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 3 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. THIRD REPORT (9/7/23, (B)(4)): LOT #3087439. THIS IS THE SAME LOT AS THE FIRST INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.00 IN THE SAFETY MECHANISM DIDN'T PROPERLY ENGAGE. THIS IS REPORT 2 OF 3. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED 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 IF ADDITIONAL INFORMATION THAT WAS OBTAINED DURING 3 DIFFERENT DATES: (B)(6). INCLUDING ADDITIONAL PHOTOS OF WHAT APPEARS TO BE THE ISSUE: 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. 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. SHARING THAT A THIRD INCIDENT HAS BEEN REPORTED: - FIRST REPORT ((B)(6)): LOT #3087439. O FOLLOW-UP (B)(6): STAFF PULLED THE NEEDLES FROM ALL SECONDARIES AND CHECKED WITH OTHER END USERS TO SEE IF THERE WERE ANY SIMILAR SITUATIONS. NONE HAVE BEEN REPORTED. WE WILL REACH OUT TO OUR VENDOR TO NOTIFY THEM OF THE ISSUE. - SECOND REPORT ((B)(6)): LOT #3150142. - THIRD REPORT ((B)(6)LOT #3087439 THIS IS THE SAME LOT AS THE FIRST INCIDENT. IT IS THE SAME RECURRING ISSUE, APPEARS TO INVOLVE ONLY THE 20G SIZE. THANK YOU, XXX, FOR ALERTING NURSING AND PROVIDERS OF THIS ISSUE AND XXX FOR INVESTIGATING THE ISSUE. IT APPEARS TO BE A MECHANISM IN THE CATHETER DEVICE THAT IS GETTING STUCK, A MANUFACTURING DEFECT INVOLVING MORE THAN ONE LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1738778 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.00 IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3087439 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown