BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 12737468 · Received November 2, 2021

    Report

    Report Number
    1710034-2021-00931
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Date of Event
    September 27, 2021
    Report Date
    November 16, 2021
    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
    SW
    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 LOTS, 0357956 AND 1140689, NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO AND OBSERVED TWO 20 GAUGE NEXIVA UNITS. ONE UNIT HAD THE NEEDLE ASSEMBLY PARTIALLY PULLED BACK THROUGH THE TIP SHIELD AND THE OTHER HAD THE NEEDLE PULLED BACK FULLY THROUGH THE TIP SHIELD. BASED OFF THE PROVIDED PHOTO THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. UNFORTUNATELY, WITHOUT A PHYSICAL SAMPLE AVAILABLE FOR EVALUATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED 2 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM HAD ISSUES WITH NEEDLE DISENGAGEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN REMOVING THE NEEDLE FROM THE DEVICE AFTER PLACEMENT THE NEEDLE WAS STUCK IN THE DEVICE AND NOT REMOVABLE AS USUAL."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1140689. MEDICAL DEVICE EXPIRATION DATE: 04/30/2024. DEVICE MANUFACTURE DATE: 05/20/2021. MEDICAL DEVICE LOT #: 0357956. MEDICAL DEVICE EXPIRATION DATE: 11/30/2023. DEVICE MANUFACTURE DATE: 12/22/2020. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED 2 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM HAD ISSUES WITH NEEDLE DISENGAGEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN REMOVING THE NEEDLE FROM THE DEVICE AFTER PLACEMENT THE NEEDLE WAS STUCK IN THE DEVICE AND NOT REMOVABLE AS USUAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1636455 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383537 SEE H.10. 30382903835370

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown