BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET/N35/20DROP/LL

    MDR report key: 10742632 · Received October 27, 2020

    Report

    Report Number
    2243072-2020-01736
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    October 1, 2020
    Report Date
    December 10, 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

    H6: INVESTIGATION SUMMARY: THE ACTUAL PRODUCT WAS RECEIVED AND CHECKED, NO ABNORMALITIES SUCH AS CLOGGING OR DEFORMATION WERE FOUND. WHEN WE CHECKED THE AIRTIGHTNESS OF OUR ACTUAL PRODUCT (THE JIS STANDARD: 50KPA, NO LEAKAGE AFTER 15 SECONDS OF PRESSURIZATION), NO LEAKAGE WAS FOUND. 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. WHEN THE RUBBER STOPPER OF THE ACTUAL INFUSION BAG WAS ENLARGED AND CONFIRMED, MULTIPLE PUNCTURE HOLES WERE FOUND. IN ADDITION, CRACKS GENERATED IN THE RUBBER STOPPER WHEN THIS PRODUCT IS CLEANED BEFORE ANALYSIS ARE ALSO INCLUDED. WHEN WE PUNCTURED ANOTHER INFUSION BAG (SALINE BAG "FUSO" 250ML SERIAL NUMBER (B)(6) WITH OUR ACTUAL PRODUCT, NO LIQUID LEAKAGE WAS OBSERVED. IT IS PRESUMED THAT THIS EVENT IS NOT DERIVED FROM OUR PRODUCT BUT DUE TO THE CHARACTERISTICS OF THE RUBBER STOPPER OF THE INFUSION CONTAINER. 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. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW THIS COMPLAINT HAS BEEN DEEMED NOT REPORTABLE. THE MATERIAL # IS NOT REGISTERED AS A MEDICAL DEVICE IN THE US AND IS NOT SIMILAR TO A MEDICAL DEVICE SOLD IN THE US. REFERENCE: (B)(6) ATTACHMENT A DEVICES MANUFACTURED IN A FACILITY THAT DOES NOT MANUFACTURE DEVICES FOR THE US MARKET. THESE DEVICES ARE SOLD OUTSIDE OF THE US AND ARE NOT SIMILAR TO BD DEVICES REGISTERED OR SOLD IN THE US. OR, SOME OF THESE MATERIAL NUMBER PRODUCTS ARE JUST NOT CONSIDERED FINISHED MEDICAL DEVICES. WE SELL THEM TO OEM COMPANIES WHO FURTHER PROCESS THEM, BUT ARE MANUFACTURED IN THE US. THIS COMPLAINT IS NOT MDR REPORTABLE. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. EVENT TYPE: NOT A REGISTERED MEDICAL DEVICE H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DOCETAXEL LEAKED FROM THE IV SET/N35/20DROP/LL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "THIS IS A REPORT ABOUT LEAKAGE (DOCETAXEL). INFUSION WAS GIVEN WITH AN INFUSION BAG + A SPIKE SET (515505-ZAT) + 515540-ZAT + AN INFUSION SET. ACCORDING TO THE INFORMATION FROM A CLINICAL NURSE, LEAKAGE OCCURRED FROM THE CONNECTION BETWEEN THE LUER (515540-ZAT) AND THE INFUSION SET OR FROM NEAR THE SPIKE NEEDLE OF THE SPIKE SET (515505-ZAT). THE DRUG USED IS DOCETAXEL."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DOCETAXEL LEAKED FROM THE IV SET/N35/20DROP/LL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "THIS IS A REPORT ABOUT LEAKAGE (DOCETAXEL). INFUSION WAS GIVEN WITH AN INFUSION BAG + A SPIKE SET (515505-ZAT) + 515540-ZAT + AN INFUSION SET. ACCORDING TO THE INFORMATION FROM A CLINICAL NURSE, LEAKAGE OCCURRED FROM THE CONNECTION BETWEEN THE LUER (515540-ZAT) AND THE INFUSION SET OR FROM NEAR THE SPIKE NEEDLE OF THE SPIKE SET (515505-ZAT). THE DRUG USED IS DOCETAXEL."

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: (B)(4). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DOCETAXEL LEAKED FROM THE IV SET/N35/20DROP/LL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THIS IS A REPORT ABOUT LEAKAGE (DOCETAXEL). INFUSION WAS GIVEN WITH AN INFUSION BAG + A SPIKE SET (515505-ZAT) + 515540-ZAT + AN INFUSION SET. ACCORDING TO THE INFORMATION FROM A CLINICAL NURSE, LEAKAGE OCCURRED FROM THE CONNECTION BETWEEN THE LUER (515540-ZAT) AND THE INFUSION SET OR FROM NEAR THE SPIKE NEEDLE OF THE SPIKE SET (515505-ZAT). THE DRUG USED IS DOCETAXEL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209454 IV SET/N35/20DROP/LL INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 2004053C

    Patients

    Seq Age Sex Outcome Treatment
    1