BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTA PLUS3 RED

    MDR report key: 11190131 · Received January 18, 2021

    Report

    Report Number
    9610847-2021-00027
    Event Type
    Malfunction
    Date Received
    January 18, 2021
    Date of Event
    December 21, 2020
    Report Date
    February 4, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 0063713. 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. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THE PROVIDED FEEDBACK MENTIONS A CRACK WITH THE DEVICE, THIS TYPE OF DEFECT IS NOT TYPICALLY RELATED TO THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CONNECTA PLUS3 RED LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE ROUTINELY CONNECTED THE INFUSION CONNECTA. IF THERE IS LIQUID LEAKAGE DURING THE INFUSION, STOPPED THE INFUSION IMMEDIATELY, CHECKED THE QUALITY OF THE CONNECTA, AND FOUND A CRACK AT THE INFUSION CONNECTA INTERFACE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CONNECTA PLUS3 RED LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE ROUTINELY CONNECTED THE INFUSION CONNECTA. IF THERE IS LIQUID LEAKAGE DURING THE INFUSION, STOPPED THE INFUSION IMMEDIATELY, CHECKED THE QUALITY OF THE CONNECTA, AND FOUND A CRACK AT THE INFUSION CONNECTA INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84088 CONNECTA PLUS3 RED INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 0063713

    Patients

    Seq Age Sex Outcome Treatment
    1