BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA CLOSED IV CATHETER SYSTEM

    MDR report key: 10920321 · Received November 30, 2020

    Report

    Report Number
    1710034-2020-00763
    Event Type
    Malfunction
    Date Received
    November 30, 2020
    Date of Event
    November 3, 2020
    Report Date
    February 8, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835172
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 12/28/2020. H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED FIVE SEALED PACKAGES FROM LOT 0092023, ONE SEALED PACKAGE FROM LOT 0092015, AND FOUR PHOTOS. THROUGH THE VISUAL EXAMINATION, THE UNITS FROM LOT 0092023 REVEALED THAT THE VENT PLUGS WERE LOOSENED FROM THE ADAPTER AND THE PACKAGING WAS DEFORMED, CONFIRMING THE DEFECTS OF VENT PLUG LOOSE AND PACKAGE DAMAGED/ DEFECTIVE. THE OBSERVED DEFORMED/SHRUNK PACKAGES ARE MOST COMMONLY A RESULT OF EXPOSURE TO EXTREME HEAT AND IS MOST LIKELY DUE TO TRANSIT OR STORAGE BUT CAN ALSO OCCUR DURING THE MANUFACTURING PROCESS. THEREFORE, BD WAS UNABLE TO DETERMINE A DEFINITE ROOT CAUSE FOR THE DEFECT PACKAGE DAMAGED/ DEFECTIVE. THE VENT PLUGS WERE INSPECTED AND NO DAMAGE WAS FOUND THAT WOULD RESULT IN THE VENT PLUGS BECOMING LOOSE. THE VENT PLUGS WERE RE-TIGHTENED DURING THE INVESTIGATION AND REMAINED INTACT FOR THE ENTIRE EVALUATION. LOOSE VENT PLUGS CAN OCCUR DURING THE MANUFACTURING PROCESS BUT BD WAS NOT ABLE TO DETERMINE A DEFINITE ROOT CAUSE FOR THE DEFECT OF VENT PLUGS LOOSE. DURING THE VISUAL EXAMINATION OF THE UNIT FROM LOT 0092015, IT WAS OBSERVED THAT THE PACKAGE WAS SEALED AND EMPTY OF PRODUCT. NO DAMAGE WAS OBSERVED TO THE PACKAGING. THE REPORTED ISSUE WAS CONFIRMED. EMPTY PACKAGES CAN OCCUR DURING THE LOADING STEP OF THE PACKAGING PROCESS. THIS WAS THE PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO AN OPERATOR ERROR IN THE PACKAGING PROCESS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 BD NEXIVA¿ CLOSED IV CATHETER SYSTEMS EXPERIENCED CATHETER BREAKAGE/SEPARATION FROM HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN OPENING THE MIDDLE PACKAGE, THE RECURRENT THROMBUS OF THE COLLAPSE NEEDLE IN THE PLASTIC SHELL FELL OFF, WHICH AFFECTED 5 PIECES THERE IS NO NEEDLE IN THE INDEPENDENT PACKAGE, 1 NEEDLE IS AFFECTED AS CONFIRMED BY SALES REP. , THIS COMPLAINT IS ABOUT THE EA PACKAGE (BOTTOM WEB AND TOP WEB) CRIMPING AND THE PART ATTACHED ON THE STRAIGHT CONNECTING PORT FELL APART NOTICED ON 5 EAS PRODUCTS, NEEDLE MISSING NOTICED ON 1 EA PRODUCT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5 BD NEXIVA CLOSED IV CATHETER SYSTEMS EXPERIENCED CATHETER BREAKAGE/SEPARATION FROM HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN OPENING THE MIDDLE PACKAGE, THE RECURRENT THROMBUS OF THE COLLAPSE NEEDLE IN THE PLASTIC SHELL FELL OFF, WHICH AFFECTED 5 PIECES THERE IS NO NEEDLE IN THE INDEPENDENT PACKAGE, 1 NEEDLE IS AFFECTED AS CONFIRMED BY SALES REP. , THIS COMPLAINT IS ABOUT THE EA PACKAGE (BOTTOM WEB AND TOP WEB) CRIMPING AND THE PART ATTACHED ON THE STRAIGHT CONNECTING PORT FELL APART NOTICED ON 5 EAS PRODUCTS, NEEDLE MISSING NOTICED ON 1 EA PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387173 BD NEXIVA CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383517 0092023 30382903835172

    Patients

    Seq Age Sex Outcome Treatment
    1