BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRM/C60/N35

    MDR report key: 9632686 · Received January 27, 2020

    Report

    Report Number
    2243072-2020-00082
    Event Type
    Malfunction
    Date Received
    January 27, 2020
    Date of Event
    December 26, 2019
    Report Date
    April 1, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    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: (1) WHEN WE CHECKED THE APPEARANCE OF OUR PRODUCT, NO ABNORMALITIES SUCH AS BREAKAGE OR MOLDING DEFECTS WERE FOUND. (2) WE CHECKED THE AIRTIGHTNESS OF OUR ACTUAL PRODUCT (THE RELEVANT JIS STANDARD: 50KPA FOR 15 SECONDS WITHOUT ANY LEAKAGE) AND FOUND NO LEAKAGE. (3) PURIFIED WATER WAS INJECTED INTO THE INFUSION BAG AND THE PRODUCT WAS PIERCED INTO THE CENTER OF THE RUBBER STOPPER. A LEAK WAS OBSERVED. (4) WHEN THE RUBBER STOPPER OF THE INFUSION BAG WAS CHECKED FOR ENLARGEMENT, MULTIPLE PUNCTURE HOLES WERE FOUND. IN ADDITION, CRACKS GENERATED IN RUBBER STOPPERS WHEN THIS PRODUCT WAS WASHED BEFORE ANALYSIS ARE ALSO INCLUDED. (5) WE PIERCED ANOTHER INFUSION BAG (PHYSIOLOGICAL SALINE SOLUTION BAG "FUSO" 250 ML SERIAL NUMBER (B)(6) WITH OUR ORIGINAL PRODUCT AND FOUND NO LEAKAGE (PHOTO 6). 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. 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. IT IS STATED THAT THERE IS. WHEN PIERCING THE SPIKE, INSERT THE RUBBER STOPPER OF THE INFUSION CONTAINER VERTICALLY WITH THE RUBBER STOPPER FACING UPWARD, AND TAKE CARE NOT TO LEAK THE LIQUID AT THE SAME TIME AS THE INSERTION. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE PRM/C60/N35 THERE WAS AN ISSUE WITH LEAKAGE. IT LEAKED FROM BETWEEN THE SPIKE NEEDLE AND THE RUBBER STOPPER OF THE INFUSION BAG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: AFTER PRIMING, DILUTED MEDICATION BY THE NEEDLE AND LEAKAGE WASN'T CONFIRMED. HOWEVER WHEN A NURSE TRIED TO GIVE IT TO THE PATIENT, IT LEAKED FROM BETWEEN THE SPIKE NEEDLE AND THE RUBBER STOPPER OF THE 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE PRM/C60/N35 THERE WAS AN ISSUE WITH LEAKAGE. IT LEAKED FROM BETWEEN THE SPIKE NEEDLE AND THE RUBBER STOPPER OF THE INFUSION BAG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: AFTER PRIMING, DILUTED MEDICATION BY THE NEEDLE AND LEAKAGE WASN'T CONFIRMED. HOWEVER WHEN A NURSE TRIED TO GIVE IT TO THE PATIENT, IT LEAKED FROM BETWEEN THE SPIKE NEEDLE AND THE RUBBER STOPPER OF THE INFUSION BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98328 PRM/C60/N35 INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other