BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8871877 · Received August 7, 2019

    Report

    Report Number
    1710034-2019-00863
    Event Type
    Malfunction
    Date Received
    August 7, 2019
    Date of Event
    July 22, 2019
    Report Date
    September 4, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THERE WERE NO SAMPLES OR PHOTOS AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION.

    Description of Event or Problem · 0

    MATERIAL NO: 383536 BATCH NO: 9122557. IT WAS REPORTED THAT DURING USE OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THE NEEDLE WAS UNABLE TO BE REMOVED FROM THE CATHETER. THE IV WAS REMOVED AND A SECOND CATHETER WAS SUCCESSFULLY PLACED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STAFF HAD AN ISSUE WITH A NEXIVA IV CATHETER SYSTEM TODAY. THEY POKED THE PATIENT, ADVANCED THE CATHETER, AND WERE UNABLE TO WITHDRAW THE NEEDLE ALL THE WAY. IT GOT STUCK. THEY HAD TO REMOVE THE ENTIRE IV AND RE-POKE THE PATIENT WITH A DIFFERENT SET. CUSTOMER STATED IN RESPONSE TO INFORMATION REQUEST, "THIS MAY HAVE BEEN AN ISOLATED EVENT; I HAVE ONLY GOTTEN ONE COMPLAINT. IT MAY HAVE BEEN USER ERROR."

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO: 383536, BATCH NO: 9122557. IT WAS REPORTED THAT DURING USE OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THE NEEDLE WAS UNABLE TO BE REMOVED FROM THE CATHETER. THE IV WAS REMOVED AND A SECOND CATHETER WAS SUCCESSFULLY PLACED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STAFF HAD AN ISSUE WITH A NEXIVA IV CATHETER SYSTEM TODAY. THEY POKED THE PATIENT, ADVANCED THE CATHETER, AND WERE UNABLE TO WITHDRAW THE NEEDLE ALL THE WAY. IT GOT STUCK. THEY HAD TO REMOVE THE ENTIRE IV AND RE-POKE THE PATIENT WITH A DIFFERENT SET. CUSTOMER STATED IN RESPONSE TO INFORMATION REQUEST, "THIS MAY HAVE BEEN AN ISOLATED EVENT; I HAVE ONLY GOTTEN ONE COMPLAINT. IT MAY HAVE BEEN USER ERROR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666524 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9122557 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other