BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SP SET

    MDR report key: 10371431 · Received August 5, 2020

    Report

    Report Number
    2243072-2020-01201
    Event Type
    Malfunction
    Date Received
    August 5, 2020
    Date of Event
    July 16, 2020
    Report Date
    October 5, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    LHI
    PMA / PMN Number
    NA
    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) WHEN WE CHECKED THE APPEARANCE OF OUR ACTUAL PRODUCT, WE FOUND NO ABNORMALITIES SUCH AS DAMAGE OR MOLDING DEFECTS. (2) WHEN PURIFIED WATER WAS INJECTED INTO THE ACTUAL INFUSION BAG AND THE ACTUAL PRODUCT MANUFACTURED BY OUR COMPANY WAS PUNCTURED INTO A RUBBER STOPPER, NO LIQUID LEAKAGE WAS OBSERVED FROM THE PUNCTURED PART. (3) WHEN THE RUBBER STOPPER OF THE ACTUAL INFUSION BAG WAS ENLARGED AND CONFIRMED, MULTIPLE PUNCTURE HOLES WERE FOUND. IT ALSO INCLUDES CRACKS IN THE RUBBER STOPPER WHEN THIS PRODUCT IS CLEANED BEFORE ANALYSIS. (4) WHEN WE PUNCTURED ANOTHER INFUSION BAG (SALINE BAG "FUSO" 250ML SERIAL NUMBER (B)(6)) WITH OUR ACTUAL PRODUCT, NO LEAKAGE WAS FOUND FROM THE PUNCTURE SITE. IT IS ESTIMATED THAT THIS EVENT IS NOT DERIVED FROM OUR PRODUCT BUT DUE TO THE CHARACTERISTICS OF THE RUBBER STOPPER OF THE INFUSION CONTAINER. FOR YOUR REFERENCE, A GUIDE HAS BEEN ISSUED BY OTSUKA PHARMACEUTICAL FACTORY, INC., AND IF THERE IS A NEEDLE HOLE DURING 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. WHEN PUNCTURING THE SPIKES, INSERT THE RUBBER STOPPER OF THE INFUSION CONTAINER VERTICALLY WITH THE RUBBER STOPPER FACING THE TOP, AND BE CAREFUL NOT TO LEAK THE LIQUID AT THE SAME TIME AS THE PUNCTURE. IN ADDITION, THE CONNECTOR LUER LOCK AT THE END OF THE ACTUAL PRODUCT WAS FOUND TO HAVE THROUGH HOLES IN THE MEMBRANE AND LIQUID LEAKAGE DUE TO REPEATED USE.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED/CORRECTED: D.10. DEVICE AVAILABLE FOR EVALUATION?: YES. D.10. RETURNED TO MANUFACTURER ON: (B)(6)2020. H.3. DEVICE RETURN TO MANUFACTURER?: YES. DEVICE EVAL. BY MANUFACTURER?: NO. OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS ATOM. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1., AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SP SET EXPERIENCED LEAKAGE AND FOREIGN MATTER CONTAMINATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE OCCURRED FROM THE AREA NEAR WHERE THE SPIKE WAS INSERTED. BD NEEDS TO INVESTIGATE WHETHER THERE WAS ANY DEFECT ON THE SPICK SET OR NOT AND WHETHER THERE WAS ANY DEFECT (HOLE) ON THE RUBBER PART OF THE INFUSION BAG. THIS COULD ALSO BE ASSOCIATED WITH THE NEEDLE INSERTION AREA DURING PREPARATION (REMICADE).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SP SET EXPERIENCED LEAKAGE AND FOREIGN MATTER CONTAMINATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE OCCURRED FROM THE AREA NEAR WHERE THE SPIKE WAS INSERTED. BD NEEDS TO INVESTIGATE WHETHER THERE WAS ANY DEFECT ON THE SPICK SET OR NOT AND WHETHER THERE WAS ANY DEFECT (HOLE) ON THE RUBBER PART OF THE INFUSION BAG. THIS COULD ALSO BE ASSOCIATED WITH THE NEEDLE INSERTION AREA DURING PREPARATION (REMICADE).

    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)(6) HAS BEEN LISTED IN AND THE (B)(6) 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 LEAKAGE AND FOREIGN MATTER CONTAMINATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE OCCURRED FROM THE AREA NEAR WHERE THE SPIKE WAS INSERTED. BD NEEDS TO INVESTIGATE WHETHER THERE WAS ANY DEFECT ON THE SPICK SET OR NOT AND WHETHER THERE WAS ANY DEFECT (HOLE) ON THE RUBBER PART OF THE INFUSION BAG. THIS COULD ALSO BE ASSOCIATED WITH THE NEEDLE INSERTION AREA DURING PREPARATION (REMICADE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830201 BD SP SET SPIKE SET LHI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other