BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 16935723 · Received May 15, 2023

    Report

    Report Number
    9610847-2023-00113
    Event Type
    Malfunction
    Date Received
    May 15, 2023
    Date of Event
    April 19, 2023
    Report Date
    July 23, 2024
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    00382903946020
    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

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THE UNITS ARE VISIBLY DIFFICULT TO CONNECT AND ALLOW AN INFLUX OF AIR INTO THE RUNNING INFUSION. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER (B)(6), LOT 3012417. THE REVIEW REVEALED THE PRODUCT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. THERE WERE NO NONCONFORMANCES, CAPAS OR ABNORMAL CONDITIONS NOTED AT THE TIME OF PRODUCTION. AT THE TIME OF THE DHR REVIEW, THERE WERE NO CHANGES TO THE PROCESS AND/OR EQUIPMENT THAT WOULD HAVE AFFECTED THE MANUFACTURING OF THE DEVICE. BASED ON THE INVESTIGATION, BD WAS NOT ABLE TO CONFIRM THE REPORTED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD CONNECTA¿ STOPCOCK AIR ENTERED THE LINE AND LEAKAGE OCCURRED AT THE CONNECTION POINT. THIS IS REPORT 1 OF 2. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: ON 19.4. AND 20.4. WE HAVE NOTICED AN INFLUX OF AIR INTO THE RUNNING INFUSION. 19.4 - PATIENT ID - (B)(6), FEMALE. 20.4 - PATIENT ID - (B)(6), MALE. WE HAVE ALSO NOTICED A LOSS OF VASOPRESSOR DUE TO LEAKAGE AT THE CONNECTION POINT WITH A CONSEQUENT RISK TO THE PATIENT DUE TO A DROP IN BLOOD PRESSURE. IN OUR OPINION, THE CAUSE IS THE POOR WORKMANSHIP OF THE LUER-LOOK CONNECTION POINT, WHICH IS ALREADY VISIBLY DIFFICULT TO CONNECT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474936 BD CONNECTA¿ STOPCOCK INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 3012417 00382903946020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female