BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 8597651 · Received May 9, 2019

    Report

    Report Number
    9610847-2019-00364
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Date of Event
    April 23, 2019
    Report Date
    August 30, 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
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8122914. 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. UNFORTUNATELY THE SAMPLE FOR THIS COMPLAINT WAS LOST IN TRANSIT TO OUR FACILITY. 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 THERE WAS A LEAKAGE DURING INFUSION WITH A BD CONNECTA¿ STOPCOCK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: DURING THE INFUSION THE LIQUID RUNS OUT FROM THE 3WAY VALVE, THE VERTICAL PART OF THE 3WV IS BROKEN.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 THERE WAS A LEAKAGE DURING INFUSION WITH A BD CONNECTA¿ STOPCOCK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: DURING THE INFUSION THE LIQUID RUNS OUT FROM THE 3WAY VALVE, THE VERTICAL PART OF THE 3WV IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387193 BD CONNECTA¿ STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8212596

    Patients

    Seq Age Sex Outcome Treatment
    1 Other