BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP SET

    MDR report key: 8716462 · Received June 20, 2019

    Report

    Report Number
    2243072-2019-01222
    Event Type
    Malfunction
    Date Received
    June 20, 2019
    Date of Event
    June 5, 2019
    Report Date
    July 11, 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

    H.6. INVESTIGATION: (1) AS A RESULT OF CHECKING THE APPEARANCE OF OUR ACTUAL PRODUCT WE RECEIVED, WE DID NOT FIND ANY ABNORMALITIES SUCH AS DAMAGE OR MOLDING DEFECTS. (2) WHEN THE AIRTIGHTNESS OF THE PRODUCT MANUFACTURED (THE RELEVANT JIS STANDARD: NO LEAK AT THE PRESSURE OF 50 KPA FOR 15 SECONDS) WAS CONFIRMED, NO LEAK WAS OBSERVED. (3) WHEN PURE WATER WAS INJECTED INTO THE INFUSION BAG ACTUAL PRODUCT AND OUR PRESENT PRODUCT WAS PUNCTURED AT THE CENTER OF THE RUBBER STOPPER, NO LIQUID LEAKAGE WAS OBSERVED. (4) WHEN THE RUBBER STOPPER PART OF THE INFUSION BAG ACTUAL PRODUCT WAS ENLARGED AND CONFIRMED, SEVERAL PUNCTURE HOLES WERE RECOGNIZED. IN ADDITION, WHEN THIS PRODUCT WAS WASHED BEFORE ANALYSIS, THE CRACK WHICH AROSE IN THE RUBBER STOPPER IS ALSO INCLUDED. (5) WHEN ANOTHER INFUSION BAG (SALINE SOLUTION BAG "FUSO" 250 ML SERIAL NUMBER (B)(6)) WAS PUNCTURED WITH OUR PRESENT PRODUCT, NO LEAK WAS OBSERVED (PHOTO 6). THIS EVENT WAS NOT DERIVED FROM OUR PRODUCT, BUT WAS PRESUMED TO BE DUE TO THE CHARACTERISTICS OF THE RUBBER STOPPER OF THE INFUSION CONTAINER. FOR REFERENCE, A GUIDANCE STATEMENT HAS BEEN ISSUED FROM OTSUKA PHARMACEUTICAL FACTORY, INC. IF THERE IS A NEEDLE HOLE AT THE TIME OF COINJECTION NEAR THE POSITION WHERE THE SPIKE IS INSERTED, IT MAY BE OPENED BY STRAIN DUE TO COMPRESSION, LEADING TO FLUID LEAKAGE IT IS STATED THAT THERE IS. WHEN PUNCTURING SPIKES, MAKE SURE THAT THE RUBBER STOPPER OF THE FLUID CONTAINER IS FACING VERTICALLY AND ENSURE THAT THE LIQUID DOES NOT LEAK AT THE SAME TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IFOSFAMIDE LEAKED FROM THE INJECTION SITE OF THE SP SET DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "CHEMO(IFOSFAMIDE) LEAKED FROM THE INJECTION SITE OF THE INFUSION BAG."

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IFOSFAMIDE LEAKED FROM THE INJECTION SITE OF THE SP SET DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CHEMO (IFOSFAMIDE) LEAKED FROM THE INJECTION SITE OF THE INFUSION BAG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508606 SP SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other