BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 7158056 · Received January 2, 2018

    Report

    Report Number
    9610847-2017-00218
    Event Type
    Malfunction
    Date Received
    January 2, 2018
    Date of Event
    December 8, 2017
    Report Date
    February 2, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903835912
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS: BD RECEIVED 80 SAMPLES FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. INSPECTION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE. DURING THE INVESTIGATION THE FOLLOWING WAS OBSERVED, THE DEVICE¿S BOX AND IV CASES WERE FOUND DAMAGE, ALSO SOME TRAY DAMAGES WERE DETECTED AS PART OF THE DEFECTIVE SAMPLE INSPECTION, ACCORDING THE INVESTIGATION THE DEFECT REPORTED CAN BE CONFIRMED AS REPORTED BUT NOT RELATED TO PACKAGING PROCESS, HOWEVER WE DON¿T KNOW IF THE DEFECT WAS GENERATED DURING THE PRODUCT SHIPPING OR USER HANDLING ALREADY THE PACKAGE COMPONENT AND CASES WERE FOUND OBVIOUSLY DAMAGE. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF REPORTED LOT NUMBER 7171974. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED AS WE COULD NOT DETERMINE WHAT CAUSED THE DAMAGE. CONCLUSION: THIS DEFECT CAN BE CAUSED DURING THE NORMAL SHIPPING OF PRODUCT OR HANDLING OF THE PRODUCT BUT COULD NOT BE CONFIRMED AS MANUFACTURING RELATED ISSUE. BASED ON AN EVALUATION OF SEVERITY AND FREQUENCY IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME, SINCE THIS ISSUE COULD NOT BE CONFIRMED AS MANUFACTURING RELATED ISSUE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    IT WAS REPORTED THAT THE STERILE PACKAGE OF THE BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM WAS OPENED BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361 BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7171974 30382903835912

    Patients

    Seq Age Sex Outcome Treatment
    1 Other