BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA CLOSED IV CATHETER SYSTEM

    MDR report key: 10708203 · Received October 20, 2020

    Report

    Report Number
    2243072-2020-01682
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    September 15, 2020
    Report Date
    December 29, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER. THE FOLLOWING FIELDS HAVE BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM SALINE LOCK LEAKED DURING USE. D.1. MEDICAL DEVICE BRAND NAME: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM D.2. MEDICAL DEVICE CATALOG#: 383536 D.2. MEDICAL DEVICE LOT#: 0051700 D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-01-31 D.5. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.2. MANUFACTURING LOCATION: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. G.5. PMA / 510(K)#: K183399 H.4. DEVICE MANUFACTURE DATE: 2020-02-20

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2020-11-19. H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED ONE PHOTOGRAPH WHICH DISPLAYED A 20GA WINGED ADAPTER AND Y-ADAPTER WITH TWO ATTACHED Q-SYTE UNITS. THROUGH THE EVALUATION OF THE PHOTOGRAPH, THE CATHETER TUBING WAS OBSERVED TO BE CUT OR BROKEN A SHORT DISTANCE FROM THE NOSE OF THE ADAPTER. THERE IS EVIDENCE OF BLOOD/MEDIA ON THE WINGS OF THE CATHETER ADAPTER AND ON THE INSIDE THREADS OF THE Q-SYTE. THE REPORTED ISSUE WAS CONFIRMED AS THE CATHETER BROKE/SEPARATED AFTER PLACEMENT. IT IS UNDETERMINED IF THIS RESULTED DUE TO A MANUFACTURING ERROR OR IF IT TOOK PLACE IN THE USER ENVIRONMENT. THE REPORTED ISSUE OF LEAKAGE AT THE LUER CONNECTION WAS ALSO CONFIRMED AND WAS LIKELY CAUSED BY INSUFFICIENT TIGHTENING OF THE Q-SYTE CONNECTOR IN THE CLINICAL SETTING AFTER SUCCESSFUL PLACEMENT OF THE CATHETER AND REMOVAL OF THE VENT PLUG. THE EXAMINATION OF THE ACTUAL UNIT DISPLAYED APPROXIMATELY 2MM OF TUBING EXTENDING FROM THE NOSE OF THE ADAPTER. THE LOOSE PIECE OF TUBING WAS PLACED BACK INTO POSITION TO DISPLAY THE ANGLE OF THE CUT. AT THE AREA OF SEPARATION, THE EDGES ARE STRAIGHT AND SLIGHTLY JAGGED, INDICATING THE CATHETER TUBING WAS CUT BY A SHARP OBJECT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM SALINE LOCK LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SALINE LOCK IN LEFT AC WAS LEAKING. I WENT TO TAKE OUT SALINE LOCK, BUT THE CANNULA TIP WAS MISSING. I WAS UNABLE TO LOCATE IT. CV SURGERY ON CALL WAS PAGED AND PATIENT WAS ASSESSED BY MD. HE SAID HE WILL ORDER ULTRASOUND."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM SALINE LOCK LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SALINE LOCK IN LEFT AC WAS LEAKING. I WENT TO TAKE OUT SALINE LOCK, BUT THE CANNULA TIP WAS MISSING. I WAS UNABLE TO LOCATE IT. CV SURGERY ON CALL WAS PAGED AND PATIENT WAS ASSESSED BY MD. HE SAID HE WILL ORDER ULTRASOUND."

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD NEXIVA¿ CLOSED IV DUAL PORT CATHETER SYSTEM SALINE LOCK LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SALINE LOCK IN LEFT AC WAS LEAKING. I WENT TO TAKE OUT SALINE LOCK, BUT THE CANNULA TIP WAS MISSING. I WAS UNABLE TO LOCATE IT. CV SURGERY ON CALL WAS PAGED AND PATIENT WAS ASSESSED BY MD. HE SAID HE WILL ORDER ULTRASOUND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173764 BD NEXIVA CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 0051700

    Patients

    Seq Age Sex Outcome Treatment
    1 Other