BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 24927300 · Received April 20, 2026

    Report

    Report Number
    2243072-2026-00291
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Date of Event
    April 1, 2026
    Report Date
    May 14, 2026
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903835119
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. THE REPORTED ISSUES OF CATHETER TIP INTEGRITY, CATHETER DEFECTIVE/ DAMAGED AND LEAKAGE WERE CONFIRMED UPON INSPECTION OF THE SAMPLE. ANALYSIS OF THE SAMPLE SHOWED THE CATHETER TIP WAS DAMAGED. THE CATHETER TUBING HAD A PUNCTURE MARK THAT CAUSED THE LEAK NEAR THE ADAPTER. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS HAVE BEEN REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. A SIMULATION WAS CARRIED OUT WHERE THE CANNULA WAS REINSERTED WHILE THE CATHETER WAS PARTIALLY IN THE TUBING. THIS SIMULATION WAS DONE DURING A FLASHBACK TEST. IT WAS OBSERVED THAT REINSERTION OF THE CANNULA WILL LEAD TO LEAKAGE FROM THE CATHETER TUBING. THE LEAK WAS CONSISTENT WITH THE RETURNED SAMPLE. THERE WAS NO ABNORMALITY DURING THE PRODUCTION RUN BASED ON THE DEVICE HISTORY RECORD REVIEW. BASED ON THE RETURNED SAMPLE, THE CANNULA PIERCED THROUGH THE CATHETER. HOWEVER, THE PUNCTURE WAS SUCCESSFULLY RECREATED WITH ANOTHER SAMPLE BY PUNCTURING THE CANNULA HALFWAY THROUGH THE CATHETER TUBING. THE MARK RECREATED HAS THE SAME CHARACTERISTIC AS THE RETURNED SAMPLE. AS MENTIONED IN THE INSTRUCTIONS FOR USE (IFU); IF THE NEEDLE IS PARTIALLY OR COMPLETELY WITHDRAWN FROM THE CATHETER TUBING DURING INSERTION, DO NOT RE-INSERT THE NEEDLE INTO THE CATHETER TUBING AS DAMAGE MAY OCCUR. THE CATHETER TIP WAS OBSERVED DAMAGED FROM THE RETURNED SAMPLE. THERE ARE VISION SYSTEMS IN PLACE TO CHECK AND ENSURE THE TIPPING OF THE CATHETER IS WITHIN SPECIFICATION. THE DAMAGED OBSERVED ON THE RETURNED SAMPLE MAY BE FROM THE USER APPLICATION PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT THE IV WITH NEXIVA CATHETER UPON OBTAINING BLOOD RETURN, BLOOD BEGAN LEAKING OUT OF CANNULA BEFORE ABLE TO ADVANCE FULLY INTO VEIN. TIP OF CANNULA INSIDE OF VEIN ALSO STARTED POINTING UPWARD CAUSING SKIN TO TENT AS PUSHING FORWARD TO ADVANCE INTO VEIN. NOTED HOLE ON SIDE OF IV CANNULA AND CROOKED CANNULA UPON REMOVAL. COMPLAINT VIA EMAIL. MEDICAL DEVICE INCIDENT REPORT TO VENDOR REQUEST FOR INVESTIGATION AND COMPLAINTS/LOT REVIEW MDIP # (B)(4). DEVICE AVAILABLE FOR INVESTIGATION: YES, PLEASE SEE THE BELOW DEVICE PROBLEM REPORT. THERE WAS NO SERIOUS HARM REPORTED. THE DEVICE IS AVAILABLE FOR INVESTIGATION (ADDITIONAL DETAILS BELOW). MDIP REPORT INCIDENT OR PROBLEM INFORMATION MDIP REFERENCE NUMBER (ID): (B)(4) DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2026. TYPE OF INCIDENT/PROBLEM: A2. FAILURE (I.E. WHILE PREPARING FOR, IN USE, AFTER USE) LEVEL OF HARM: TEMPORARY HARM OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): INCIDENT DETAILS: INITIATING IV WITH NEXIVA CATHETER UPON OBTAINING BLOOD RETURN, BLOOD BEGAN LEAKING OUT OF CANNULA BEFORE ABLE TO ADVANCE FULLY INTO VEIN. TIP OF CANNULA INSIDE OF VEIN ALSO STARTED POINTING UPWARD CAUSING SKIN TO TENT AS PUSHING FORWARD TO ADVANCE INTO VEIN. NOTED HOLE ON SIDE OF IV CANNULA AND CROOKED CANNULA UPON REMOVAL. PROCEDURE: PERIPHERAL IV INITIATION DEVICE INFORMATION DEVICE NAME/DESCRIPTION: CATHETER IV PASSIVE SAFETY NON-WINGED CLOSED SYSTEM SINGE PORT YELLOW 24GX19MM NEXIVA MANUFACTURER: BECTON DICKINSON CANADA INC MANUFACTURER CODE/MODEL: 383511 SERIAL OR LOT NUMBER: (B)(6) EXPIRY DATE: 2028-05-31 SUPPLIER: SUPPLIER/CATALOGUE NUMBER: 333-383511 . IS THE DEVICE RETAINED? YES, NUMBER OF DEVICES: 1 WIPED, CONTAINED, LABELLED? WIPED, DOUBLED BAGGED (IF CONSUMABLE), AND LABELLED AS PER INSTRUCTIONS DEVICE HANDLING HAZARDS BLOOD AND/OR BODY FLUID CONTAMINATED / CYTOTOXIC, CHEMOTHERAPY OR HAZARDOUS MEDICATION INVESTIGATION REQUEST EXPECTED TYPE OF INVESTIGATION: ACTUAL DEVICE TESTED; LOT REVIEW E-MAIL ADDRESS FOR PERSON HOLDING DEVICE: SITE SHIPPING ADDRESS: CLINICAL CONTACT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286738 NEXIVA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 5177054 00382903835119

    Patients

    Seq Age Sex Outcome Treatment
    1