BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 16219770 · Received January 20, 2023

    Report

    Report Number
    9610847-2023-00006
    Event Type
    Malfunction
    Date Received
    January 20, 2023
    Date of Event
    January 3, 2023
    Report Date
    February 15, 2023
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION SUMMARY: BD WAS NOT ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE SAMPLES OR PICTURES WERE NOT PROVIDED TO PERFORM BETTER INVESTIGATION. A DEVICE HISTORY RECORD REVIEW AS COMPLETED FOR PROVIDED MATERIAL NUMBER 394605, LOT 2091994. THE PRODUCT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. THERE WERE NO NONCONFORMANCE(S) OR ABNORMAL CONDITIONS NOTED AT THE TIME OF PRODUCTION. THIS CONDITION IS NORMAL IN THE NOGALES MANUFACTURING PROCESS SINCE A LETTER IS PLACED AT THE END OF THE BATCH OF THE UNIT PACKAGE WHICH INDICATES THE SHIFT IN WHICH THE BATCH OF PRODUCT IS MANUFACTURED. THIS IS BY REQUIREMENT OF OUR PACKAGING PROCEDURE PG-172SP WHICH MENTIONS THAT THE PRODUCT MUST CONTAIN THIS LETTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OUTER PACKAGING OF THE BD CONNECTA¿ STOPCOCK HAD THE LOT LABELED AS 2091994, WHILE THE INNER LABEL LISTED IT AS 2091994B. THIS OCCURRED WITH 5000 PRODUCTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "AT THE DISTRIBUTOR, WHEN ENTERING THE PLATFORM, IT WAS FOUND THAT THE BATCH NUMBER OF THE PRODUCT PACKAGE WAS INCONSISTENT WITH THE BATCH NUMBER OF THE INTERNAL PRODUCT. OUTER PACKAGING BATCH NUMBER: 2091994; INTERNAL PRODUCT BATCH NUMBER: 2091994B."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OUTER PACKAGING OF THE BD CONNECTA¿ STOPCOCK HAD THE LOT LABELED AS 2091994, WHILE THE INNER LABEL LISTED IT AS 2091994B. THIS OCCURRED WITH 5000 PRODUCTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "AT THE DISTRIBUTOR, WHEN ENTERING THE PLATFORM, IT WAS FOUND THAT THE BATCH NUMBER OF THE PRODUCT PACKAGE WAS INCONSISTENT WITH THE BATCH NUMBER OF THE INTERNAL PRODUCT. OUTER PACKAGING BATCH NUMBER: 2091994; INTERNAL PRODUCT BATCH NUMBER: 2091994B."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895626 BD CONNECTA¿ STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 2091994

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown