BEUDAMED
    FDA Adverse Event Injury Summary report: N

    22 G X 1.00 IN. BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 6870735 · Received September 15, 2017

    Report

    Report Number
    9610847-2017-00078
    Event Type
    Injury
    Date Received
    September 15, 2017
    Date of Event
    August 3, 2017
    Report Date
    September 26, 2017
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: NO SAMPLE OR PHOTO WAS RETURNED FOR EVALUATION. NO SAMPLE RETENTION FOR NEXIVA DIFFUSICS PRODUCT. LOT NUMBER / PRODUCT FAMILY HISTORY: REGARDING COMPLAINT HISTORY CHECK THIS IS THE 1ST COMPLAINT RELATED TO DEFECT REPORTED WITH THE CONDITION OF REACTION (IRRITATION/INFLAMMATION) FOR THE LOT 7082539 CATALOG 383591, IT HAS BEEN RECEIVED IN THE NEXIVA DIFFUSCIS FAMILY, THE SAMPLE WAS NOT RECEIVED FOR EVALUATION. DHR/BHR REVIEW DHR FOR LOT NUMBER 7082539 WAS REVIEWED AND NO QN¿S THERE ARE RELATED TO THIS LOT, DURING THE DHR REVIEW NO ISSUE DURING OUR Q.A TECH SAMPLING WAS DETECTED. MATERIAL 383591 WITH LOT NUMBER 7082539 WAS MANUFACTURED ON MARCH 23 2017, THE AREA, EQUIPMENT AND WORK STATION WERE CLEANING CORRECTLY ACCORDING INTERNAL PROCEDURES. DURING DHR REVIEW IT WAS CONFIRMED THAT THE LINE CLEARANCE WAS PERFORMED PROPERLY. ALL RELEVANT INFORMATION DURING THE DHR REVIEW SHOWN THAT MEET ALL ESTABLISHED MANUFACTURING CRITERIA. MANUFACTURING REVIEW DURING THE MANUFACTURING ASSEMBLY PROCESS, EACH WORK STATION IS CLEANED AND VERIFIED AS PART OF OUR LOCAL PROCEDURES IN ORDER TO SANITIZE THE AREA AND AVOID POSSIBLE CONTAMINATION TO THE PRODUCT. IF SOME ISSUE IS DETECTED DURING THE LINE CLEARANCE VERIFICATION THE LINE CANNOT START RUN PRODUCTION UNTIL THIS PART OF PROCESS IS COMPLETED. REFERENCE TO KNOWN ISSUE: FIVE CUSTOMER COMPLAINTS FROM DIFFERENT LOT NUMBERS HAS BEEN REPORTED SINCE 2013 TO DATE FOR ASSOCIATED PRODUCT FAMILY (NEXIVA) TO THIS FAILURE MODE, BUT NONE OF THEM HAS BEEN CONFIRMED AS A MANUFACTURING RELATED. CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. THE CUSTOMER COMPLAINT COULD WAS NOT CONFIRMED ALREADY A RETURN SAMPLE WAS NOT AVAILABLE FOR EVALUATION. ROOT CAUSE: WE COULD NOT CONFIRM A SPECIFIC ROOT CAUSE FOR THIS ISSUE SINCE AN ACTUAL SAMPLE OR PHOTO WAS NOT AVAILABLE FOR EVALUATION, ACCORDING THIS MATTER WE COULD NOT DETERMINE IF IT WAS USER OR MANUFACTURING RELATED ISSUE. CAPA DETERMINATION RESULTS: NO CORRECTIVE ACTION WAS INITIATED SINCE THIS ISSUE COULD NOT BE CONFIRMED AS USER OR MANUFACTURING RELATED ISSUE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IV CONTRAST 325PSI 5CC PER SECOND FOR A CTA USING A 22 G X 1.00 IN. BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM, THE PATIENT STATED HIS ARM WAS BURNING. UPON EXAMINATION, THE MAJORITY OF CONTRAST WAS IN THE RIGHT AC AREA. THE PATIENT WAS HOSPITALIZED FOR 24 HOURS AND TREATED WITH ALTERING COOL AND WARM COMPRESSES, ARM ELEVATION AND TYLENOL. UPON 24-HOUR FOLLOW-UP WITH THE PATIENT, IT WAS REPORTED THE SWELLING DECREASED, PAIN WAS AT A ¿0¿ AND THERE WAS SOME RESIDUAL BRUISING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648738 22 G X 1.00 IN. BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization