BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ 3-WAY STOPCOCK

    MDR report key: 13668002 · Received March 4, 2022

    Report

    Report Number
    9610847-2022-00084
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    February 21, 2022
    Report Date
    March 30, 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

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1033314. MEDICAL DEVICE EXPIRATION DATE: 2024-01-31. DEVICE MANUFACTURE DATE: 2021-02-16 . MEDICAL DEVICE LOT #: 0157587. MEDICAL DEVICE EXPIRATION DATE: 2023-05-31. DEVICE MANUFACTURE DATE: 2020-07-15. 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: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 16-MAR-2022. H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. THE REPORTED ISSUE WAS NOT CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLE. THE SAMPLE WAS VISUALLY INSPECTED FOR ANY SIGNS OF DAMAGE THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT, BUT NO DAMAGES WERE OBSERVED. THE SAMPLE WAS ALSO TESTED TO EVALUATE THE CONNECTION OF THE DEVICE WITH ANOTHER SET. THE SAMPLE WAS CONNECTED TO ANOTHER SET AND TESTED FOR LEAKAGE AND NO LEAKAGE WAS OBSERVED INDICATING A PROPER CONNECTION. BD CANNOT DETERMINE A MANUFACTURING RELATED ROOT CAUSE SINCE THE DEFECT 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 WHILE USING BD CONNECTA¿ 3-WAY STOPCOCK PRODUCT DISCONNECTED WITHOUT PROMPTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONNECTA CONNECTION IS WEAK AND THEY TEND TO DISCONNECT WHEN CONNECTED TO AN INFUSION SET. THE ROTATING PART DISCONNECTS AFTER CONNECTING TO LL CONNECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD CONNECTA¿ 3-WAY STOPCOCK PRODUCT DISCONNECTED WITHOUT PROMPTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONNECTA CONNECTION IS WEAK AND THEY TEND TO DISCONNECT WHEN CONNECTED TO AN INFUSION SET. THE ROTATING PART DISCONNECTS AFTER CONNECTING TO LL CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534093 BD CONNECTA¿ 3-WAY STOPCOCK INTRAVASCULAR ADMINISTRATION SET FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 1126366

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown