BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ DIFFUSICS¿ 20G X 1.00 IN

    MDR report key: 8805145 · Received July 18, 2019

    Report

    Report Number
    9610847-2019-00473
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    July 2, 2019
    Report Date
    August 9, 2019
    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
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SINCE A LOT NUMBER COULD NOT BE CONNECTED TO THE DEVICE IDENTIFIED IN THE COMPLAINT, BD INVESTIGATORS COULD NOT CONDUCT A DEVICE HISTORY REVIEW FOR THIS EVENT. ADDITIONALLY, A SAMPLE HAS NOT BEEN SUBMITTED FOR EVALUATION AND TESTING, PREVENTING BD ENGINEERS FROM CONDUCTING A FULL INVESTIGATION AND DETERMINING A ROOT CAUSE OF THE FAILURE MODE IDENTIFIED IN YOUR DESCRIPTION OF THE EVENT. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EXTENSION TUBING BECAME SEPARATED FROM THE HUB DURING USE WITH A BD NEXIVA¿ DIFFUSICS¿ 20G X 1.00 IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EXTENSION TUBING BECAME DISCONNECTED FROM HUB. UNCLEAR AS TO WHETHER OR NOT THEIR WAS FORCE PUT ON THE TUBING TO CAUSE IT TO FAIL.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTENSION TUBING BECAME SEPARATED FROM THE HUB DURING USE WITH A BD NEXIVA¿ DIFFUSICS¿ 20G X 1.00 IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EXTENSION TUBING BECAME DISCONNECTED FROM HUB. UNCLEAR AS TO WHETHER OR NOT THEIR WAS FORCE PUT ON THE TUBING TO CAUSE IT TO FAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599341 BD NEXIVA¿ DIFFUSICS¿ 20G X 1.00 IN INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other