BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA¿ STOPCOCK

    MDR report key: 9318493 · Received November 13, 2019

    Report

    Report Number
    9610847-2019-00681
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    October 28, 2019
    Report Date
    January 15, 2020
    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
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PICTURE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PROVIDED PICTURE, IT WAS DETERMINED THAT LEAKAGE OCCURRED AT THE INJECTION PORT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 8180509. THE REVIEW DID NOT REVEAL ANY SIGNS OF NON-CONFORMANCE DURING THE PRODUCTION PROCESS. IT IS PROBABLE THAT THE LEAKAGE RESULTED FROM IMPROPER TUBING ASSEMBLY. THE ENGINEERING TEAM ASSESSED THE ASSEMBLY PROCESS AND FOUND A WORN STATION THAT COULD HAVE PRODUCED THIS INCIDENT. SINCE THE PRODUCTION OF LOT NUMBER 8180509, A CORRECTIVE AND PREVENTIVE ACTION PLAN, CAPA#629955, WAS INITIATED AND COMPLETED FOR THE ISSUE OF INJECTION VALVE LEAKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD CONNECTA¿ STOPCOCK THERE IS A PLUG IN THE FILTER. LEAKAGE TOOK PLACE AT UNION BETWEEN THE KEY AND THE EXTENSION. THIS OCCURRED ON 10 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: CONNECTA 7CMS IS FILTERED BY FILTER PLUG. THE LEAKAGE OCCURRED IN THE UNION BETWEEN THE KEY AND THE EXTENSION. THERE WAS NO DAMAGE TO THE PATIENT/HEALTH PROFESSIONAL. THERE WAS NO EXPOSURE OF BLOOD OR CHEMOTHERAPY TO THE SKIN OR MUCOUS.

    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 OF THE BD CONNECTA¿ STOPCOCK THERE IS A PLUG IN THE FILTER. LEAKAGE TOOK PLACE AT UNION BETWEEN THE KEY AND THE EXTENSION. THIS OCCURRED ON 10 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: CONNECTA 7CMS IS FILTERED BY FILTER PLUG. THE LEAKAGE OCCURRED IN THE UNION BETWEEN THE KEY AND THE EXTENSION. THERE WAS NO DAMAGE TO THE PATIENT/HEALTH PROFESSIONAL. THERE WAS NO EXPOSURE OF BLOOD OR CHEMOTHERAPY TO THE SKIN OR MUCOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108113 BD CONNECTA¿ STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8180509

    Patients

    Seq Age Sex Outcome Treatment
    1 Other