BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 16740806 · Received April 14, 2023

    Report

    Report Number
    9610847-2023-00087
    Event Type
    Malfunction
    Date Received
    April 14, 2023
    Date of Event
    March 5, 2023
    Report Date
    April 18, 2023
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    UDI-DI
    00382903946020
    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 AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY IT WAS REPORTED THERE WAS A CONNECTION ISSUE. 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 394602, LOT 2122315. ACCORDING TO THE DOCUMENTED RECORDS, THE PRODUCT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. THERE WERE NO NON-CONFORMANCES, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD CONNECTA¿ STOPCOCK THE CAP WAS LOOSE AND COULD NOT BE TIGHTENED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO CORONARY HEART DISEASE, AND RETURNED TO THE WARD AFTER CORONARY ARTERY BYPASS GRAFTING. ESMOLOL WAS PUMPED AT 16:40 ON (B)(6) 2023, AND THE JUGULAR VEIN CHANNEL WAS INCREASED. IF IT CANNOT BE TIGHTENED, REPLACE IT WITH A NEW ONE IMMEDIATELY, WITHOUT CAUSING LOSS OR INJURY TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD CONNECTA¿ STOPCOCK THE CAP WAS LOOSE AND COULD NOT BE TIGHTENED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO CORONARY HEART DISEASE, AND RETURNED TO THE WARD AFTER CORONARY ARTERY BYPASS GRAFTING. ESMOLOL WAS PUMPED AT 16:40 ON MARCH 5, 2023, AND THE JUGULAR VEIN CHANNEL WAS INCREASED. IF IT CANNOT BE TIGHTENED, REPLACE IT WITH A NEW ONE IMMEDIATELY, WITHOUT CAUSING LOSS OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991449 BD CONNECTA¿ STOPCOCK INTRAVASCULAR ADMINISTRATION SET FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 2122315 00382903946020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown