BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTA PLUS3 10CM WHITE

    MDR report key: 8975052 · Received September 9, 2019

    Report

    Report Number
    9610847-2019-00556
    Event Type
    Malfunction
    Date Received
    September 9, 2019
    Date of Event
    August 22, 2019
    Report Date
    October 22, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9031772. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF CONNECTA PLUS3 10CM WHITE EXPERIENCED A STOPCOCK/CAP LOOSE CONNECTION/SEPARATED/DETACHED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAP HAS FALLEN OFF WHILE GIVING IV FLUID TO PATIENT. IT HAS FALLEN OFF WHILE PATIENT IS IN THE BED AND BLOOD STAINED FLUID WAS FOUND IN PATIENT¿S BED. CONNECTA SIDE CAPS FALL OFF TOO OFTEN ALREADY WHEN OPENING THE PACKAGE OR SIDE CAP FALLS OFF WHEN RUNNING IV- FLUIDS.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF CONNECTA PLUS3 10 CM WHITE EXPERIENCED A STOPCOCK/CAP LOOSE CONNECTION/SEPARATED/DETACHED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAP HAS FALLEN OFF WHILE GIVING IV FLUID TO PATIENT. IT HAS FALLEN OFF WHILE PATIENT IS IN THE BED AND BLOOD STAINED FLUID WAS FOUND IN PATIENT¿S BED. CONNECTA SIDE CAPS FALL OFF TOO OFTEN ALREADY WHEN OPENING THE PACKAGE OR SIDE CAP FALLS OFF WHEN RUNNING IV- FLUIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767531 CONNECTA PLUS3 10CM WHITE STOP COCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 9031772

    Patients

    Seq Age Sex Outcome Treatment
    1 Other