BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCKS CONNECTA PLUS 3 7 CM WHITE BLEND

    MDR report key: 7026261 · Received November 13, 2017

    Report

    Report Number
    9610847-2017-00142
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 19, 2017
    Report Date
    February 23, 2018
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FMG
    PMA / PMN Number
    K974083
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THREE SAMPLES WERE RECEIVED FOR EVALUATION. LEAK TESTING WAS PERFORMED ON EACH UNIT AND NO LEAKAGE WAS OBSERVED. WE WERE UNABLE TO DETERMINE A ROOT CAUSE FOR THIS EVENT BASED ON THE PROVIDED SAMPLES AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. DHR REVIEW SHOWS MATERIAL 394945 WITH LOT NUMBER 7152548 WAS MANUFACTURED ON JUN-29-2017 BY EQUIPMENT KA56. NO QN'S OR OTHER EXTRAORDINARY EVENTS THAT CAN EXPLAIN THE INCIDENT HAVE BEEN RELATED. QUALITY RECORDS HAVE BEEN CONSULTED FOR TRACKING AND TRENDING PURPOSES AND NO ISSUES LIKE THIS ARE DETECTED. PROCESS FMEA RM5943 WAS REVIEWED AND THERE ARE PROPER CONTROLS IN PLACE TO DETECT PRODUCT MALFUNCTIONS. CONCLUSION: 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

    INVESTIGATION SUMMARY BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. CUSTOMER REPORTED LEAKAGE ISSUES; HOWEVER NO SAMPLE WAS AVAILABLE FOR EVALUATION WHICH IS ESSENTIAL TO PERFORM A BETTER INVESTIGATION. INVESTIGATION CONCLUSION BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. CUSTOMER REPORTED LEAKAGE ISSUES; HOWEVER NO SAMPLE WAS AVAILABLE FOR EVALUATION WHICH IS ESSENTIAL TO PERFORM A BETTER INVESTIGATION. QUALITY RECORDS HAVE BEEN CONSULTED FOR TRACKING AND TRENDING PURPOSES AND NO ISSUES LIKE THIS ARE DETECTED WHICH MEANS PRETTY LOW OCCURRENCE. PRODUCT IS FUNCTIONAL TESTED AND NO INCIDENTS WITH LEAKAGES HAVE BEEN REPORTED. PROCESS FMEA (B)(4) WAS REVIEWED AND THERE ARE PROPER CONTROLS IN PLACE TO DETECT PRODUCT MALFUNCTIONS. ALWAYS REFER TO IFU FOR PRODUCT USAGE RECOMMENDATIONS. WE WILL KEEP MONITORING THE MANUFACTURING PROCESS AND IN CASE ANY EMERGING TREND IS DETECTED, FURTHER ACTIONS WILL BE TAKEN IF NECESSARY. ROOT CAUSE DESCRIPTION BASED ON INVESTIGATION RESULTS TO DATE, ROOT CAUSE FOR MANUFACTURING PROCESS CANNOT BE DETERMINED. DHR - 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. MANUFACTURING REVIEW- NO ISSUES DETECTED FROM MANUFACTURING PROCESS, MAINTENANCE OR CALIBRATED INSTRUMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD CONNECTA¿ STOPCOCKS CONNECTA PLUS 3 7 CM WHITE BLEND MALFUNCTIONED DURING USE AS THE CONNECTION BETWEEN THE EXTENSION TUBE AND THREE WAY STOP COCK WAS FOUND TO BE LEAKING. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803269 BD CONNECTA¿ STOPCOCKS CONNECTA PLUS 3 7 CM WHITE BLEND STOPCOCK FMG BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7152548

    Patients

    Seq Age Sex Outcome Treatment
    1 Other