BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA PLUS3 BLUE

    MDR report key: 21231033 · Received January 24, 2025

    Report

    Report Number
    9610847-2025-00004
    Event Type
    Malfunction
    Date Received
    January 24, 2025
    Date of Event
    December 30, 2024
    Report Date
    January 27, 2025
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    UDI-DI
    00382903946020
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 394602 AND LOT NUMBER 4061569. 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. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    NONE REPORTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONNECTA PLUS3 BLUE LEAKAGE DURING PREOPERATIVE PREPARATION FOR INFUSION, THE INFUSION TEE WAS FOUND TO BE LEAKING DURING VENTING, RECONNECTED AND STILL LEAKING, AND WAS REPLACED WITH A NEW INFUSION TEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662560 BD CONNECTA PLUS3 BLUE STOPCOCK, I.V. SET FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 4061569 00382903946020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown