BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SP SET

    MDR report key: 10418076 · Received August 17, 2020

    Report

    Report Number
    2243072-2020-01259
    Event Type
    Malfunction
    Date Received
    August 17, 2020
    Date of Event
    July 27, 2020
    Report Date
    September 17, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 9/4/2020. H.6. INVESTIGATION: (1) WHEN WE CHECKED THE APPEARANCE OF OUR ACTUAL PRODUCT, WE FOUND NO ABNORMALITIES SUCH AS DAMAGE OR MOLDING DEFECTS (2) WHEN WE CHECKED THE AIRTIGHTNESS OF OUR ACTUAL PRODUCT (THE JIS STANDARD: 50KPA, NO LEAKAGE AFTER 15 SECONDS OF PRESSURIZATION), NO LEAKAGE WAS FOUND (3) PURIFIED WATER WAS INJECTED INTO THE ACTUAL INFUSION BAG, AND WHEN THE ACTUAL PRODUCT MANUFACTURED BY OUR COMPANY WAS PUNCTURED INTO A RUBBER STOPPER, LIQUID LEAKAGE WAS OBSERVED (4) WHEN THE RUBBER STOPPER OF THE ACTUAL INFUSION BAG WAS ENLARGED AND CONFIRMED, MULTIPLE PUNCTURE HOLES WERE FOUND. IN ADDITION, CRACKS GENERATED IN THE RUBBER STOPPER WHEN THIS PRODUCT IS CLEANED BEFORE ANALYSIS ARE ALSO INCLUDED. (5) WHEN WE PUNCTURED ANOTHER INFUSION BAG (SALINE BAG "FUSO" 250ML SERIAL NUMBER (B)(6)) WITH OUR ACTUAL PRODUCT, NO LIQUID LEAKAGE WAS OBSERVED IT IS PRESUMED THAT THIS EVENT IS NOT DERIVED FROM OUR PRODUCT BUT DUE TO THE CHARACTERISTICS OF THE RUBBER STOPPER OF THE INFUSION CONTAINER. IF THERE IS A NEEDLE HOLE AT THE TIME OF MIXED INJECTION NEAR THE POSITION WHERE THE SPIKE IS INSERTED, IT MAY OPEN DUE TO DISTORTION DUE TO COMPRESSION AND LEAD TO LIQUID LEAKAGE. IT IS STATED THAT THERE IS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SP SET EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN INSERTING THE SPIKE NEEDLE INTO A HIKARI PHARMACEUTICAL'S SALINE BAG, LEAKAGE OCCURRED. THE MEDICATION PREPARED IS GEMCITABINE.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). OEM MANUFACTURE: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SP SET EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN INSERTING THE SPIKE NEEDLE INTO A HIKARI PHARMACEUTICAL'S SALINE BAG, LEAKAGE OCCURRED. THE MEDICATION PREPARED IS GEMCITABINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876519 BD SP SET IV SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other