BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA STOPCOCK

    MDR report key: 11069885 · Received December 23, 2020

    Report

    Report Number
    9610847-2020-00430
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    November 27, 2020
    Report Date
    March 8, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 2/4/2021. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 0150048. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE NON-BD PRODUCT AND ONE CONNECTA PRODUCT WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. INSPECTION AND LEAKAGE TESTING WAS PERFORMED FOR THE CONNECTA PRODUCT AND NO NEGATIVE RESULTS WERE RETRIEVED. BASED ON THE INVESTIGATION RESULTS, A CAUSE RELATED TO THE BD MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS INCIDENT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD CONNECTA¿ STOPCOCK EXPERIENCED LEAKAGE AT THE CONNECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE OF THE 3-WAY STOPCOCK. LEAKAGE OCCURRED ON THE BOTTOM/UNDERSIDE BETWEEN THE WHITE AND TRANSPARENT PIECE OF PLASTIC.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD CONNECTA¿ STOPCOCK EXPERIENCED LEAKAGE AT THE CONNECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE OF THE 3-WAY STOPCOCK. LEAKAGE OCCURRED ON THE BOTTOM/UNDERSIDE BETWEEN THE WHITE AND TRANSPARENT PIECE OF PLASTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534313 BD CONNECTA STOPCOCK STOP COCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 0150048

    Patients

    Seq Age Sex Outcome Treatment
    1