BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET/N35/20DROP/F/LL

    MDR report key: 8881100 · Received August 9, 2019

    Report

    Report Number
    2243072-2019-01662
    Event Type
    Malfunction
    Date Received
    August 9, 2019
    Date of Event
    July 17, 2019
    Report Date
    October 14, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    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: WHEN WE CONFIRMED THE AIRTIGHTNESS OF THE TWO ACTUAL PRODUCTS (JIS STANDARD: 150KPA FOR 15 MINUTES WITH NO PRESSURE LEAKAGE), ONE OF THEM WAS FOUND TO LEAK FROM THE FILTER. AS FOR THE OTHER ONE, NO LEAKAGE WAS OBSERVED FROM ANY PART. AFTER REQUESTING THAT BOTH LEAKS WERE FOUND, WE ASKED THE FILTER MANUFACTURER TO INVESTIGATE THE MATERIAL. ACCORDING TO THE RESULTS OF A SURVEY CONDUCTED BY THE FILTER MANUFACTURER AND DISTRIBUTOR, LIQUID LEAKAGE OCCURRED AT THE WELDED PART OF THE FILTER HOUSING, AND A WELD FAILURE WITH A THIN WELD END WAS OBSERVED AT THE LIQUID LEAKED PART. AS A RESULT OF REVIEWING ALL MANUFACTURING-RELATED RECORDS, NO RECORD OF NON-CONFORMANCE PROBLEMS WAS FOUND, BUT THE WELD END WAS UNEVEN DUE TO THE FACT THAT THIS PRODUCT WAS WELDED WITHOUT BEING POSITIONED CORRECTLY VERTICALLY FROM THE STATE OF THE WELDED PART OF THE ACTUAL PRODUCT. IT WAS ESTIMATED THAT LIQUID LEAKAGE OCCURRED IN THE PRESSURIZED STATE FROM THE THIN PART. REGARDING THE OTHER ONE, NO ABNORMALITY WAS FOUND IN THE APPEARANCE INSPECTION AND PRESSURE LEAK INSPECTION, SO THE CAUSE COULD NOT BE IDENTIFIED. IT WAS CONFIRMED THAT THE FILTER MANUFACTURER AND MANUFACTURER HAVE IMPLEMENTED IMPROVEMENT MEASURES SINCE THE PRODUCTION IN FEBRUARY 2019 (THE CYLINDER BUILT IN THE WELDER MAY HAVE MALFUNCTIONED AND THE CYLINDER HAS BEEN COMPLETELY REPLACED). IN ADDITION, WE HAVE ALSO STARTED VISUAL INSPECTION OF ALL PARTS FOR DEFECTIVE WELDING BEFORE ASSEMBLY AND STRENGTHENED MONITORING TO PREVENT THE RECURRENCE OF SIMILAR EVENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH IV SET/N35/20DROP/F/LL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "515544-ZAT X2 WERE PREPARED TO GIVE DRUG TO THE PATIENT. SALINE LEAKED FROM THE UPPER PART OF THE FILTER AT THE SAME TIME WHEN CONDUCTED PRIMING."

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: 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 LEAKAGE OCCURRED DURING USE WITH IV SET/N35/20DROP/F/LL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "515544-ZAT X2 WERE PREPARED TO GIVE DRUG TO THE PATIENT. SALINE LEAKED FROM THE UPPER PART OF THE FILTER AT THE SAME TIME WHEN CONDUCTED PRIMING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674852 IV SET/N35/20DROP/F/LL INTERVASCULAR CATHETER FOZ BECTON DICKINSON 1811302C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other