BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD IV SET SN404 W/O BP Y-CONN

    MDR report key: 7282765 · Received February 20, 2018

    Report

    Report Number
    2243072-2018-00056
    Event Type
    Malfunction
    Date Received
    February 20, 2018
    Date of Event
    January 29, 2018
    Report Date
    April 19, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS UNKNOWN. THE SAMPLE Y CONNECTOR WAS ALSO BROKEN. SBDM COULD NOT FIND ANY FOREIGN MATTER ON THE SAMPLE, UPON CLARIFICATION WITH BD (B)(4), THERE ARE SOME WHITE PART ON THE Y CONNECTOR WHICH IS PERCEIVED AS FOREIGN MATTER BY CUSTOMER. HOUSE SAMPLE INSPECTION: AS LOT NUMBER IS UNKNOWN, SBDM INSPECTED TOTAL OF (B)(4) LOTS OF (B)(4) PCS EACH HOUSE SAMPLES, WHICH WERE MANUFACTURED FROM 31 OCT 2017 TO 19 DEC 2017, BASING ON THE AWARENESS DATE OF THE COMPLAINTS. THE INSPECTION YIELDED NO ABNORMALITY. DEVICE HISTORY RECORD REVIEW: SBDM CHECKED MANUFACTURING RECORDS SUCH AS RECEIVING INSPECTION REPORT, PROCESS INSPECTION REPORT AND FINISHED PRODUCT TEST REPORT OF THE SUSPECTED HOUSE SAMPLES (LOT NO. 2710311, 2711101, 2711212, 2711271 & 2712191), THERE WAS NO ABNORMALITY ON THE MANUFACTURING RECORDS. THE APPEARANCE COLOR OF A NORMAL Y-CONNECTOR IS CLEAR, BUT THE COMPLAINT SAMPLE DISPLAY SOME PORTION OF Y-CONNECTOR BEING WHITE COLOR. SBDM ANALYZED THE WHITE COLOR PART (SUSPECTED FM) OF Y-CONNECTOR USING INFRARED SPECTROMETRY. THE RESULTS CONFIRM THE WHITE COLOR PART IS NOT FOREIGN MATTER, IT DISPLAYS THE SAME PROPERTIES AS THE REST OF Y-CONNECTOR, WHICH RAW MATERIAL IS ACRYLONITRILE BUTADIENE STYRENE(ABS). CONCLUSION: BASED ON THE INVESTIGATION RESULT OF THE COMPLAINT CASE, FM IN THE I.V SET Y-CONNECTOR, SBDM RECEIVED BROKEN COMPLAINT SAMPLE WITHOUT FM BUT ONLY WHITE PART IN THE Y-CONNECTOR. SBDM ANALYZE IR TEST COMPLAINT SAMPLE, WHITE COLOR PART OF Y-CONNECTOR WHICH IS SUSPECTED AS FM, AND THE RESULT IS THAT WHITE COLOR PART IS NOT FM, BUT ABS, WHICH IS Y-CONNECTOR MATERIAL. LIKELY CAUSE IS THAT THE ABS COULD TURN WHITE WHEN IT IS DAMAGED OR CHEMICALLY REACT WITH CERTAIN FLUID.

    Additional Manufacturer Narrative · 1

    (B)(6). FOR OEM MANUFACTURING SITES: IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(6) HAS BEEN LISTED AS GREATER ASIA IS AN OEM MANUFACTURING SITE. 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 FOREIGN MATTER WAS OBSERVED INSIDE THE BD IV SET (B)(4) W/O BP Y-CONN. FOUND BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125510 BD IV SET SN404 W/O BP Y-CONN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON UNKOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other