BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 7827176 · Received August 29, 2018

    Report

    Report Number
    9610847-2018-00278
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Date of Event
    August 8, 2018
    Report Date
    September 28, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    K173354
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY REPORT FOR LOT NUMBER 6022523 WAS REVIEWED, NO RELATED ABNORMALITIES WERE FOUND. MATERIAL NUMBER (B)(4) FOR LOT 6022523 WAS MANUFACTURED FEBRUARY 2016. THIS IS THE FIRST INSTANCE OF THIS FAILURE MODE WITH THIS LOT NUMBER. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED, WITH NO DEFECTS BEING NOTED DURING FINAL ASSEMBLY OR IN PACKAGING VISUAL INSPECTIONS. UNFORTUNATELY A SAMPLE COULD NOT BE OBTAINED FOR THE PURPOSE OF THE INVESTIGATION. INVESTIGATION CONCLUSION: SINCE NO SAMPLE OR PHOTO WAS RETURNED FOR EVALUATION THE EXACT ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM NEEDLE DIDN'T RETRACT AFTER USE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM NEEDLE DIDN'T RETRACT AFTER USE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667522 BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 6022523

    Patients

    Seq Age Sex Outcome Treatment
    1 Other