BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ PLUS STOPCOCK

    MDR report key: 12823879 · Received November 16, 2021

    Report

    Report Number
    9610847-2021-00552
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    October 19, 2021
    Report Date
    January 19, 2022
    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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 12/2/2021 . H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE 5 SAMPLES FROM MAT 394995, LOT 1120585 SUBMITTED FOR EVALUATION. THE REPORTED ISSUE WAS NOT CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. DURING INSPECTION THERE WERE NO ABNORMAL CONDITIONS OR DAMAGES ON THE RETURNED SAMPLES. THE SAMPLES ALSO UNDERWENT OUR INTERNAL LEAKAGE TESTING AND DURING TESTING, NONE OF THE 5 SAMPLES SHOWED ANY LEAKAGE. BD CANNOT CONFIRM A MANUFACTURING ROOT CAUSE OF THE DEFECT SINCE THE DEFECT WAS NOT CONFIRMED DURING SAMPLE EXAMINATION AND TESTING. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED BD CONNECTA¿ PLUS STOPCOCK HAD ISSUES WITH LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): ¿I HAVE RECEIVED ADDITIONAL WORRISOME REPORTS FROM THE SURGICAL CENTER ABOUT DIFFERENT WARDS EXPERIENCING LEAKAGES AS WELL, SO THAT ALL CLINICS OF THE WHOLE UNIVERSITY HOSPITAL ARE NOW AFFECTED BY THIS.¿

    Description of Event or Problem · 0

    IT WAS REPORTED BD CONNECTA¿ PLUS STOPCOCK HAD ISSUES WITH LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: ¿I HAVE RECEIVED ADDITIONAL WORRISOME REPORTS FROM THE SURGICAL CENTER ABOUT DIFFERENT WARDS EXPERIENCING LEAKAGES AS WELL, SO THAT ALL CLINICS OF THE WHOLE UNIVERSITY HOSPITAL ARE NOW AFFECTED BY THIS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720691 BD CONNECTA¿ PLUS STOPCOCK I.V. SET STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 1120585

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown