BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET/N35/J/20DROP/F/STD/65CM/LL

    MDR report key: 8170171 · Received December 17, 2018

    Report

    Report Number
    2243072-2018-01814
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    November 26, 2018
    Report Date
    March 6, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD COULD NOT FIND VISUAL ABNORMALITY IN THE SAMPLE. AS A LOT NUMBER IS UNKNOWN FOR THIS INCIDENT, A DHR CANNOT BE COMPLETED. AS FOR THE ACTUAL PRODUCT 1 (SERIAL NUMBER: (B)(4)), WE CONFIRMED THE AIRTIGHTNESS OF THE ACTUAL PRODUCT (2 PIECES) (JIS STANDARD: 150 KPA FOR 15 MINUTES WITHOUT WATER LEAKAGE) , LEAK WAS NOT RECOGNIZED FROM ANY PLACE. AS FOR THE ACTUAL ITEM 2 (SERIAL NUMBER: (B)(4)), AS INDICATED, LEAKAGE WAS RECOGNIZED FROM THE BOTTOM OF THE FILTER. THEREFORE WE ASKED THE MANUFACTURER OF FILTER TO INVESTIGATE THE RELEVANT PARTS. IN ADDITION, THIS PRODUCT WAS NOT FOUND TO BE ABNORMAL IN THE SHIPPING TEST (JIS AIRTIGHTNESS STANDARD: 150 KPA FOR 15 MINUTES UNDER PRESSURE IN THE RELEVANT PRODUCTION LOT), NO ABNORMALITY WAS FOUND IN THE SAMPLING INSPECTION N = 8). ACCORDING TO THE SURVEY RESULTS BY THE FILTER VENDOR, THE LEAK OCCURRED FROM THE WELDED PART OF THE HOUSING OF THE FILTER UNDER CONDITIONS OF PRESSURIZATION OF 50 KPA OR MORE, AND WELDING FAILURE WAS FOUND TO BE THIN AT THE WELD EDGE AT THE LEAK POINT). AS A RESULT OF INSPECTION OF ALL MANUFACTURING RELATED RECORDS, NO RECORD OF NONCONFORMITY PROBLEM WAS RECOGNIZED, BUT WELDING END BECAME NONUNIFORM DUE TO WELDING WITHOUT CORRECT POSITIONING OF THIS PRODUCT CORRECTLY FROM THE STATE OF THE WELDED PORTION OF ACTUAL PRODUCT , IT WAS PRESUMED THAT LIQUID LEAKAGE OCCURRED UNDER PRESSURE FROM THE THINNER PART.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SET/N35/J/20DROP/F/STD/65CM/LL HAD LEAKAGE FROM UNDER THE FILTER.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN SECTIONS AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED LOT NUMBER [1712202C, 1710232C] WAS NOT FOUND FOR MATERIAL NUMBER [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SET/N35/J/20DROP/F/STD/65CM/LL HAD LEAKAGE FROM UNDER THE FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010025 SET/N35/J/20DROP/F/STD/65CM/LL SET/N35/J/20DROP/F/STD/65CM/LL FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other