BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA STOPCOCK

    MDR report key: 9764121 · Received February 27, 2020

    Report

    Report Number
    9610847-2020-00063
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Date of Event
    February 3, 2020
    Report Date
    March 23, 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
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 9220680. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT AND ALL INSPECTIONS WERE FOUND TO BE WITHIN SPECIFICATION. TO FURTHER INVESTIGATE THIS ISSUE, SEVEN PHYSICAL SAMPLES WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION, SIX OF THE SEVEN SAMPLES DISPLAYED KINKED TUBING, HOWEVER, NO FURTHER SIGNS OF TUBING DAMAGE OR CRACKING WERE OBSERVED. AT THIS POINT IN TIME, A DEFINITE CAUSE RELATED TO THE MANUFACTURING PROCESS CANNOT BE DETERMINED FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBE IS KINKED PRIOR TO USE WITH A BD CONNECTA¿ STOPCOCK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE WITH THE CONNECTA STOPCOCK WITH EXTENSION SET; THE TUBE IS SO BENT THAT IT CANNOT BE STRAIGHTENED AND THEREFORE CANNOT BE USED.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBE IS KINKED PRIOR TO USE WITH A BD CONNECTA¿ STOPCOCK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE WITH THE CONNECTA STOPCOCK WITH EXTENSION SET; THE TUBE IS SO BENT THAT IT CANNOT BE STRAIGHTENED AND THEREFORE CANNOT BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230526 BD CONNECTA STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 9220680

    Patients

    Seq Age Sex Outcome Treatment
    1 Other