BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA PLUS3 WHITE PEGS

    MDR report key: 19447557 · Received June 3, 2024

    Report

    Report Number
    9610847-2024-00155
    Event Type
    Malfunction
    Date Received
    June 3, 2024
    Date of Event
    April 27, 2024
    Report Date
    June 11, 2024
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    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

    IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 394601 AND LOT NUMBER 3093294. 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. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONNECTA PLUS3 WHITE PEGS HAD CONNECTION ISSUES ON THE (B)(6) THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR INTERMITTENT BLOODY STOOLS, CONTINUOUS INTRAVENOUS PUMPING OF MEDICATION, AND ON THE (B)(6) AT 8:00 P.M., HE WAS GIVEN A REPLACEMENT OF FOUR TEE CONNECTIONS FOR INFUSION, AND AT 9:05 P.M., THE PATIENT'S FAMILY MEMBERS COMPLAINED THAT THE TEE CONNECTIONS WERE DISLODGED, AND THAT THE INFUSION EXUDED ABOUT 25 ML OF INFUSION, SO HE WAS GIVEN A SUSPENSION OF THE INFUSION, AND THE INFUSION PATHWAY AND TEE CONNECTORS WERE REPLACED ANEW, WITH NO HARM CAUSED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630661 BD CONNECTA PLUS3 WHITE PEGS STOPCOCK, I.V. SET FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 3093294

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown