BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 7706241 · Received July 20, 2018

    Report

    Report Number
    9610847-2018-00220
    Event Type
    Malfunction
    Date Received
    July 20, 2018
    Date of Event
    June 22, 2018
    Report Date
    August 28, 2018
    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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: NO. THE DEVICE HISTORY REPORT FOR LOT NUMBER 8011519 WAS REVIEWED, NO RELATED ABNORMALITIES WERE FOUND. MATERIAL NUMBER (B)(4) FOR LOT 8011519 WAS MANUFACTURED ON JAN-27-2018. THIS IS THE FIRST INSTANCE OF THIS FAILURE MODE WITH THIS LOT NUMBER. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED, WITH NO DEFECTS BEING NOTED DURING FINAL ASSEMBLY OR IN PACKAGING VISUAL INSPECTIONS. A SAMPLE COULD NOT BE OBTAINED FOR THE PURPOSE OF THE INVESTIGATION. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE BD CONNECTA STOPCOCK HAD ¿LEAKAGE FROM THE CONNECTION¿. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    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 DURING USE THE BD CONNECTA¿ STOPCOCK HAD ¿LEAKAGE FROM THE CONNECTION¿. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549983 BD CONNECTA¿ STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8011519

    Patients

    Seq Age Sex Outcome Treatment
    1 Other