BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA PLUS3 BLUE

    MDR report key: 18220417 · Received November 28, 2023

    Report

    Report Number
    9610847-2023-00337
    Event Type
    Malfunction
    Date Received
    November 28, 2023
    Date of Event
    November 1, 2023
    Report Date
    January 31, 2024
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    UDI-DI
    00382903946020
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 394602 AND LOT NUMBER 3060919. 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.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONNECTA PLUS3 BLUE LABEL WAS MISMATCH THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; WAREHOUSE PERSONNEL FEEDBACK TO OPEN THE PRODUCT PACKAGING FOUND THAT THE PRODUCT LABEL OF THE SMALL PACKAGE AND THE OUTER PACKAGING LABEL IS INCONSISTENT WITH THE SMALL PACKAGE LABEL BATCH NUMBER BEHIND MORE THAN ONE LETTER QUANTITY 200 PCS, WITH PHOTOS, TEMPORARY SAMPLES CAN NOT BE RETURNED, THE NEED FOR GREEN CLAIMS, THE NEED FOR A LETTER OF REPLY, THE NEED TO COMPLAIN ABOUT THE LETTER OF ACCEPTANCE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537682 BD CONNECTA PLUS3 BLUE STOPCOCK, I.V. SET FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 3060919 00382903946020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown