BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCKS CONNECTA PLUS WHITE BLEND

    MDR report key: 7025523 · Received November 13, 2017

    Report

    Report Number
    9610847-2017-00143
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 19, 2017
    Report Date
    January 30, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    K974083
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED 52 UNITS FOR ANALYSIS. LEAK TESTING WAS PERFORMED ON EACH OF THE RETURNED UNITS AND NO LEAKAGE WAS OBSERVED. WE WERE UNABLE TO DETERMINE A ROOT CAUSE FOR THIS OCCURRENCE BASED ON THE PROVIDED SAMPLES. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. QUALITY RECORDS HAVE BEEN CONSULTED FOR TRACKING AND TRENDING PURPOSES AND NO ISSUES LIKE THIS ARE DETECTED. DHR PERFORMED SHOWED MATERIAL (B)(4) WITH LOT NUMBER 7152548 WAS MANUFACTURED ON JUN 29, 2017 BY EQUIPMENT (B)(4). NO QN¿S OR OTHER EXTRAORDINARY EVENTS THAT CAN EXPLAIN THE INCIDENT HAVE BEEN RELATED. PROCESS FMEA RM5943 WAS REVIEWED AND THERE ARE PROPER CONTROLS IN PLACE TO DETECT PRODUCT MALFUNCTIONS. BASED ON INVESTIGATION RESULTS TO DATE, ROOT CAUSE FOR MANUFACTURING PROCESS CANNOT BE DETERMINED. BASED ON AN EVALUATION OF SEVERITY AND FREQUENCY IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. WE WILL KEEP MONITORING THE MANUFACTURING PROCESS AND IN CASE ANY EMERGING TREND IS DETECTED, FURTHER ACTIONS WILL BE TAKEN IF NECESSARY.

    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 A BD CONNECTA¿ STOPCOCKS CONNECTA PLUS 3 7 CM WHITE BLEND LEAKED DURING USE. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803233 BD CONNECTA¿ STOPCOCKS CONNECTA PLUS WHITE BLEND STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7152548

    Patients

    Seq Age Sex Outcome Treatment
    1 Other