BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP SET

    MDR report key: 10221905 · Received July 1, 2020

    Report

    Report Number
    2243072-2020-00977
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Date of Event
    June 10, 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
    JA
    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: 2020-07-07. H.6. INVESTIGATION SUMMARY : (1) WHEN WE CHECKED THE APPEARANCE OF THE ACTUAL PRODUCT WE RECEIVED, NO ABNORMALITIES SUCH AS DAMAGE OR DEFECTIVE MOLDING WERE FOUND. (2) 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. (3) PURIFIED WATER WAS INJECTED INTO THE INFUSION BAG ACTUAL PRODUCT, AND THE ACTUAL PRODUCT MANUFACTURED BY OUR COMPANY WAS PUNCTURED INTO THE RUBBER STOPPER. NO LIQUID LEAKAGE WAS OBSERVED. (4) 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 IN THE RUBBER STOPPER WHEN IT WAS WASHED BEFORE ANALYSIS. (5) 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 LET THE LIQUID LEAK AT THE SAME TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SP SET LEAKED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE BETWEEN THE RUBBER STOPPER OF AN INFUSION BAG AND SPIKE SET WAS FOUND.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. 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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SP SET LEAKED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE BETWEEN THE RUBBER STOPPER OF AN INFUSION BAG AND SPIKE SET WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680377 SP SET SPIKE FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other