BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SP SET

    MDR report key: 9363465 · Received November 22, 2019

    Report

    Report Number
    2243072-2019-02634
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Date of Event
    October 30, 2019
    Report Date
    January 6, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    LHI
    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 SUMMARY: (1) WHEN WE CHECKED THE APPEARANCE OF OUR PRODUCT, NO ABNORMALITIES SUCH AS BREAKAGE OR MOLDING DEFECTS WERE FOUND. NO ANOMALY FOUND ON DHR. (2) WE CHECKED THE AIRTIGHTNESS OF OUR PRODUCT (THE RELEVANT JIS STANDARD: 50KPA FOR 15 SECONDS WITHOUT ANY LEAKAGE) AND FOUND NO LEAKAGE. (3) WHEN PURIFIED WATER WAS INJECTED INTO THE INFUSION BAG AND THE PRODUCT WAS PIERCED INTO THE CENTER OF THE RUBBER STOPPER, NO LEAKAGE WAS OBSERVED. (4) WHEN THE RUBBER STOPPER OF THE INFUSION BAG WAS CHECKED FOR ENLARGEMENT, MULTIPLE PUNCTURE HOLES WERE FOUND. IN ADDITION, WHEN THIS PRODUCT IS WASHED BEFORE ANALYSIS, CRACKS GENERATED IN THE RUBBER STOPPER ARE ALSO INCLUDED. (5) WHEN WE PUNCTURED ANOTHER INFUSION BAG (PHYSIOLOGICAL SALINE SOLUTION BAG ¿FUSO¿ 250 ML SERIAL NUMBER (B)(6) ) WITH OUR ORIGINAL PRODUCT, NO LIQUID LEAKAGE WAS OBSERVED. IT IS PRESUMED THAT THIS EVENT DID NOT ORIGINATE FROM OUR PRODUCTS BUT WAS DUE TO THE CHARACTERISTICS OF THE RUBBER STOPPER OF THE INFUSION CONTAINER. OTSUKA PHARMACEUTICAL FACTORY HAS ISSUED A GUIDE LETTER FOR IT'S USE. IF THERE IS A NEEDLE HOLE AT THE TIME OF CO-INJECTION NEAR THE POSITION WHERE THE SPIKE WAS INSERTED, STRAIN DUE TO COMPRESSION MAY OPEN AND LEAD TO LIQUID LEAKAGE. WHEN PIERCING THE SPIKE, INSERT THE RUBBER STOPPER OF THE INFUSION CONTAINER VERTICALLY WITH THE TOP FACING, AND BE CAREFUL NOT TO LEAK THE LIQUID AT THE SAME TIME AS THE INSERTION. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE BD¿ SP SET HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: A ROBOT PREPARED PACLITAXEL AND PUNCTURED SPIKE SET. HCP CONFIRMED LEAKAGE BETWEEN THE SPIKE SET AND PUNCTURED POINT OF INFUSION BAG.

    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 AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE BD¿ SP SET HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: A ROBOT PREPARED PACLITAXEL AND PUNCTURED SPIKE SET. HCP CONFIRMED LEAKAGE BETWEEN THE SPIKE SET AND PUNCTURED POINT OF INFUSION BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161159 BD¿ SP SET PHASEAL ADMINISTRATION SET LHI BECTON DICKINSON 1907052C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other