BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 17487974 · Received August 9, 2023

    Report

    Report Number
    1710034-2023-00893
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    July 26, 2023
    Report Date
    August 31, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835164
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH A PHOTO OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 3072356, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO AND OBSERVED A NOTE WRITTEN ON THE LABEL STATING, "TIP FOLDED OVER WHEN ADVANCING CATH." HOWEVER, THE ACTUAL DEVICE WAS NOT VISIBLE IN THE PROVIDED PHOTO. THEREFORE, BASED OFF THE PROVIDED PHOTO THE ENGINEER COULD NOT VERIFY THE REPORTED DEFECT. SINCE NO DEFECTS WERE VISIBLE IN THE PROVIDED PHOTO A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM NEEDLE WAS DIFFICULT TO DISENGAGE FROM THE VEIN. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SEVERAL COMPLAINTS FROM AREA 1 NURSES TODAY AS WELL AS LAB AGAIN. I HAD SEVERAL 20G'S THAT WOULD BEND IN THE VEIN AGAIN AND CAUSED THE IV TO BLOW. WITNESS THIS TIME. XX, XX, XX, XX AMONG OTHERS COMPLAINED TODAY ABOUT THE ISSUES. ALSO, SEVERAL C/O THE NEEDLE STICKING WHEN PULLING IT OUT WHICH CAUSES YOU TO LOSE THE IV. IT IS JUST NOT THE SAME AND FEELS VERY CHEAPLY MADE AND IT IS NOT EVERYONE BUT MANY STILL. I AM NOT SURE IF LABS ISSUE HAS MADE IT PAST XX, THEY ARE REPORTING THEIR BUTTERFLY IS NOW FLOWING IN THE OPPOSITE DIRECTION, I AM UNSURE IF SHE MEANT WHEN THEY HAVE FINISHED USING? THIS REALLY NEEDS TO BE INVESTIGATED AS WELL. ADDITIONAL INFO RECEIVED ON 31-JULY-23 I BELIEVE THAT THE NEEDLE IS STICKING WHEN ATTEMPTING TO PULL IT OUT AND THE CATHETER IS BENDING IN THE VEIN. THE ER'S FIRST REPORTED EVENT WAS ON 7/19. I CAN'T SPEAK TO ANY ISSUES THAT LAB IS HAVING. I ONLY HAVE TWO ACTUAL DOCUMENTED EVENTS. 7/19 AND 7/27. THE NURSES WHO ALSO ENCOUNTERED PROBLEMS ON 7/19 DIDN'T DOCUMENT ANYTHING. AGAIN, I CAN'T SPEAK ABOUT WHAT LAB EXPERIENCED. NEITHER OF THE DOCUMENTED INCIDENTS CAUSED PATIENT HARM OR REQUIRED ADDITIONAL MEDICAL INTERVENTIONS"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM NEEDLE WAS DIFFICULT TO DISENGAGE FROM THE VEIN. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SEVERAL COMPLAINTS FROM AREA 1 NURSES TODAY AS WELL AS LAB AGAIN. I HAD SEVERAL 20G'S THAT WOULD BEND IN THE VEIN AGAIN AND CAUSED THE IV TO BLOW. WITNESS THIS TIME. XX, XX, XX, XX AMONG OTHERS COMPLAINED TODAY ABOUT THE ISSUES. ALSO, SEVERAL C/O THE NEEDLE STICKING WHEN PULLING IT OUT WHICH CAUSES YOU TO LOSE THE IV. IT IS JUST NOT THE SAME AND FEELS VERY CHEAPLY MADE AND IT IS NOT EVERYONE BUT MANY STILL. I AM NOT SURE IF LABS ISSUE HAS MADE IT PAST XX, THEY ARE REPORTING THEIR BUTTERFLY IS NOW FLOWING IN THE OPPOSITE DIRECTION, I AM UNSURE IF SHE MEANT WHEN THEY HAVE FINISHED USING? THIS REALLY NEEDS TO BE INVESTIGATED AS WELL. ADDITIONAL INFO RECEIVED ON 31-JULY-23. I BELIEVE THAT THE NEEDLE IS STICKING WHEN ATTEMPTING TO PULL IT OUT AND THE CATHETER IS BENDING IN THE VEIN. THE ER'S FIRST REPORTED EVENT WAS ON (B)(6). I CAN'T SPEAK TO ANY ISSUES THAT LAB IS HAVING. I ONLY HAVE TWO ACTUAL DOCUMENTED EVENTS. (B)(6). THE NURSES WHO ALSO ENCOUNTERED PROBLEMS ON (B)(6) DIDN'T DOCUMENT ANYTHING. AGAIN, I CAN'T SPEAK ABOUT WHAT LAB EXPERIENCED. NEITHER OF THE DOCUMENTED INCIDENTS CAUSED PATIENT HARM OR REQUIRED ADDITIONAL MEDICAL INTERVENTIONS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688512 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903835164

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown