BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 13214616 · Received January 10, 2022

    Report

    Report Number
    9610847-2021-00648
    Event Type
    Malfunction
    Date Received
    January 10, 2022
    Date of Event
    December 15, 2021
    Report Date
    January 27, 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
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE LOT #: AN INVALID LOT # OF 102214D WAS PROVIDED BY THE INITIAL REPORTER 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 1033314. D4. MEDICAL DEVICE EXPIRATION DATE: 1/31/2024. H4: DEVICE MANUFACTURE DATE: 2/16/2021. H6: INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE 2 SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE WAS NOT CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. NO DAMAGES OR ABNORMAL CONDITIONS WERE OBSERVED ON EITHER OF THE SAMPLES. THE SAMPLES UNDERWENT OUR INTERNAL LEAKAGE TESTING AND SHOWED NO SIGNS OF LEAKAGE. BD CANNOT DETERMINE A MANUFACTURING ROOT CAUSE SINCE THE FAILURE WAS NOT CONFIRMED. 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 THAT THE BD CONNECTA¿ STOPCOCK EXPERIENCED LOOSE CONNECTION, AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF THE STOPCOCK PLUGS RELEASED AND FLUID FLOW OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD CONNECTA¿ STOPCOCK EXPERIENCED LOOSE CONNECTION, AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF THE STOPCOCK PLUGS RELEASED AND FLUID FLOW OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181283 BD CONNECTA¿ STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 1033314

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown