BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.25 IN

    MDR report key: 16877269 · Received May 5, 2023

    Report

    Report Number
    2243072-2023-00753
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    April 12, 2023
    Report Date
    July 4, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835370
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.25 IN WAS CUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT 2: IV CAT PART WAS SQUISHED, CATHETER AND NEEDLE MISSING. D1: MEDICAL DEVICE BRAND NAME: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.25 IN D2: MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. D4: UDI #: (01)(B)(6) D4: MEDICAL DEVICE CATALOG #: 383537 D4: MEDICAL DEVICE LOT #: 2342272 D4: MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2025 H4: DEVICE MANUFACTURE DATE: 08-DEC-2022 G2: MANUFACTURING LOCATION: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. G.5. PMA / 510(K)#: K183399 D10: DEVICE AVAILABLE FOR EVALUTION?YES. D10: RETURNED TO MANUFACTURER ON: 12-JUN-2023 H6: INVESTIGATION SUMMARY BD RECEIVED AN OPENED 20 GAUGE NEXIVA UNITS FROM LOT 2342272 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED THAT THE EXTENSION TUBING HAD BROKEN OFF IN A STRAIGHT LINE AND THE TUBING WAS FLATTENED AT THE BREAK POINT. THIS WAS INDICATIVE THAT THE TUBING WAS PROBABLY CAUGHT IN THE SEAL DURING PACKAGING. THE DEVICE WAS ALSO MISSING THE NEEDLE AND CATHETER. THEREFORE, BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECTS. IT WAS DETERMINED THAT THESE WERE MANUFACTURING DEFECTS THAT OCCURRED DUE TO THE PACKAGING PROCESS.

    Additional Manufacturer Narrative · 0

    ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, NJ WAS USED AS A PLACE HOLDER. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.25 IN WAS CUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT 2: IV CAT PART WAS SQUISHED, CATHETER AND NEEDLE MISSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIC BD IV CATHETER EXPERIENCED TUBING KINKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT 2: IV CAT PART WAS SQUISHED, CATHETER AND NEEDLE MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1691557 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.25 IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383537 2342272 30382903835370

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown