BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP SET

    MDR report key: 9126152 · Received September 26, 2019

    Report

    Report Number
    2243072-2019-02136
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    September 9, 2019
    Report Date
    November 4, 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: (1) AFTER CONFIRMING THE APPEARANCE OF THE PRODUCT, WE FOUND NO ABNORMALITIES SUCH AS DAMAGE OR MOLDING DEFECTS. (2) AFTER CONFIRMING THE AIRTIGHTNESS OF THE ACTUAL PRODUCT (THE RELEVANT JIS STANDARD: NO LEAKAGE WHEN PRESSURIZED FOR 50 KPA FOR 15 SECONDS), NO LEAKAGE WAS FOUND. (3) PURIFIED WATER WAS INJECTED INTO THE ACTUAL INFUSION BAG, AND THE ACTUAL PRODUCT WAS PUNCTURED IN THE CENTER OF THE RUBBER STOPPER. NO LIQUID LEAKAGE WAS OBSERVED. (4) WHEN THE RUBBER STOPPER PART OF THE ACTUAL INFUSION BAG WAS ENLARGED, MULTIPLE PUNCTURE HOLES WERE OBSERVED. IN ADDITION, WHEN THIS PRODUCT IS CLEANED BEFORE ANALYSIS, IT INCLUDES CRACKS IN THE RUBBER PLUG. (5) WHEN WE PUNCTURED OUR PRODUCT IN ANOTHER INFUSION BAG (PHYSIOLOGICAL SALINE BAG ¿FUSO¿ 250 ML, PRODUCTION NUMBER 17F22C), NO LIQUID LEAKAGE WAS OBSERVED. THIS EVENT WAS NOT CAUSED BY OUR PRODUCTS, BUT WAS PRESUMED TO BE DUE TO THE CHARACTERISTICS OF THE RUBBER STOPPER OF THE INFUSION CONTAINER. A GUIDANCE STATEMENT HAS BEEN ISSUED BY OTSUKA PHARMACEUTICAL FACTORY CO., LTD. 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 STRAIN FROM COMPRESSION AND LEAD TO LIQUID LEAKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED BEFORE USE WITH A SP SET. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "AFTER PREPARING NIVOLUMAB, IT LEAKED. THEN HCP PUNCTURED AND DRAW THE DRUG. HCP SUSPECTS LEAKAGE OCCURRED DUE TO SPIKE SET."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 BEFORE USE WITH A SP SET. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "AFTER PREPARING NIVOLUMAB, IT LEAKED. THEN HCP PUNCTURED AND DRAW THE DRUG. HCP SUSPECTS LEAKAGE OCCURRED DUE TO SPIKE SET."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920616 SP SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other