BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 8331441 · Received February 12, 2019

    Report

    Report Number
    9610847-2019-00150
    Event Type
    Malfunction
    Date Received
    February 12, 2019
    Date of Event
    January 21, 2019
    Report Date
    April 25, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    UDI-DI
    30382903065470
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBERS 8152925 & 8151681. OUR RECORDS SHOW THAT A TREND FOR LEAKAGE HAS BEEN DETECTED IN THE BD CONNECTA PRODUCT FAMILY. 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. ADDITIONALLY, OUR ENGINEERS WERE ABLE TO DUPLICATE THIS EVENT THROUGH THE LEAKAGE TESTING OF THE SUBMITTED DEVICE. A SUBSEQUENT REVIEW OF OUR MANUFACTURING LINE DETERMINED THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS AN ABNORMALITY IN THE EQUIPMENT RESPONSIBLE FOR TUBING ASSEMBLY. CAPA#(B)(4) WAS INITIATED. BASED ON INVESTIGATION RESULTS TO DATE, FOR LEAKAGE ISSUE (IN INJECTION VALVE) ROOT CAUSE WAS ASSOCIATED TO A BAD TUBING ASSEMBLY BY STATION 5 OF EQUIPMENT VH59.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD CONNECTA¿ STOPCOCK HAD AN ISSUE WITH LEAKAGE. THE LEAK WAS ON THE PORT NEAREST THE END OF THE LINE, NOT ON THE 3 WAY TAP BIT OF THE LINE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD CONNECTA STOPCOCK HAD AN ISSUE WITH LEAKAGE. THE LEAK WAS ON THE PORT NEAREST THE END OF THE LINE, NOT ON THE 3 WAY TAP BIT OF THE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123656 BD CONNECTA¿ STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 815681 30382903065470

    Patients

    Seq Age Sex Outcome Treatment
    1 Other