BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SP SET

    MDR report key: 10075739 · Received May 20, 2020

    Report

    Report Number
    2243072-2020-00794
    Event Type
    Malfunction
    Date Received
    May 20, 2020
    Date of Event
    April 30, 2020
    Report Date
    July 27, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 5/29/2020. H.6. INVESTIGATION: (1) WHEN THE APPEARANCE OF THE ACTUAL PRODUCT WAS CHECKED THAT WE RECEIVED, NO ABNORMALITIES SUCH AS DAMAGE OR DEFECTIVE MOLDING WERE FOUND. WE CONFIRMED THE AIRTIGHTNESS OF THE ACTUAL PRODUCT MANUFACTURED BY OUR COMPANY (THE RELEVANT JIS STANDARD: NO LEAK BY PRESSURIZATION OF 50 KPA FOR 15 SECONDS), AND NO LEAK WAS OBSERVED. PURIFIED WATER WAS POURED INTO THE ACTUAL PRODUCT OF THE INFUSION BAG, AND THE ACTUAL PRODUCT MANUFACTURED BY OUR COMPANY WAS PUNCTURED INTO THE RUBBER STOPPER. NO LIQUID LEAKAGE WAS OBSERVED. WHEN THE RUBBER STOPPER OF THE ACTUAL INFUSION BAG WAS ENLARGED AND CONFIRMED, MULTIPLE PUNCTURE HOLES WERE FOUND. NOTE THAT THIS PRODUCT ALSO INCLUDES CRACKS THAT OCCURRED IN THE RUBBER STOPPER WHEN THIS PRODUCT WAS WASHED BEFORE ANALYSIS. WHEN ANOTHER INFUSION BAG (PHYSIOLOGICAL SALINE SOLUTION BAG "FUSO" 250ML, SERIAL NUMBER (B)(6) ) WAS PUNCTURED WITH OUR ACTUAL PRODUCT, NO LIQUID LEAKAGE WAS OBSERVED. WE PRESUME THAT THIS EVENT IS NOT DUE TO OUR PRODUCT, BUT DUE TO THE CHARACTERISTICS OF THE RUBBER STOPPER OF THE INFUSION CONTAINER. FOR REFERENCE, A GUIDELINE HAS BEEN ISSUED BY THE OTSUKA PHARMACEUTICAL FACTORY CO., LTD., AND IF THERE IS A NEEDLE HOLE DURING MIXED INJECTION NEAR THE POSITION WHERE THE SPIKE WAS PIERCED, THE STRAIN DUE TO COMPRESSION MAY OPEN AND LEAD TO LIQUID LEAKAGE. IT IS STATED THAT THERE IS. WHEN PUNCTURING THE SPIKES, INSERT THE RUBBER STOPPER OF THE INFUSION CONTAINER VERTICALLY TOWARD THE TOP, AND BE CAREFUL NOT TO LEAK THE LIQUID AT THE SAME TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ SP SET EXPERIENCED THE INFUSION ADAPTER PUNCTURING THE IV BAG DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CISPLATIN LEAKED FROM THE SPIKE SET INSERTED PART OF THE INFUSION BAG.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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. OEM MANUFACTURE: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD¿ SP SET EXPERIENCED THE INFUSION ADAPTER PUNCTURING THE IV BAG DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CISPLATIN LEAKED FROM THE SPIKE SET INSERTED PART OF THE INFUSION BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537470 BD SP SET INFUSION ADAPTER FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other