BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA PLUS3 BLUE

    MDR report key: 20050770 · Received August 23, 2024

    Report

    Report Number
    9610847-2024-00236
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 11, 2024
    Report Date
    September 19, 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

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 394602 AND LOT NUMBER 3181290. 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

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONNECTA PLUS3 BLUE LEAKED. ON (B)(6) 2024, THE PATIENT WAS ADMITTED TO OUR HOSPITAL BECAUSE OF KIDNEY STONES, AND AT 10:30 A.M. ON (B)(6) IN COMPLIANCE WITH THE DOCTOR'S ORDERS, THE MEDICAL STAFF NORMALLY USED THE INFUSION TEE TO GIVE THE PATIENT AN INFUSION, AND AT 10:35 A.M., THERE WAS A LEAKAGE OF FLUID FROM THE TEE, RESULTING IN THE LEAKAGE OF MEDICATION. AT 10:36 A.M., THE MEDICAL STAFF THEN REPLACED THE TEE WITH ANOTHER INFUSION TEE TO CONTINUE THE TREATMENT, WHICH DELAYED THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618184 BD CONNECTA PLUS3 BLUE STOPCOCK, I.V. SET FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 3181290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown