BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTA PLUS3 WHITE PEGS

    MDR report key: 20727514 · Received November 19, 2024

    Report

    Report Number
    9610847-2024-00353
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    October 30, 2024
    Report Date
    December 24, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMG
    UDI-DI
    00382903946013
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 394601 AND LOT NUMBER 4061448. 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

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    SOME ITEMS SEEM TO BE BADLY WELDED/CONNECTED, AND FLUID LEAKED UNDER PRESSURE I HAVE A CUSTOMER WHO SENT ME BACK 1 TAP BOX REFERENCE 394601 LOT 4061448. IT WOULD BE BADLY WELDED AND WOULD CAUSE LEAKAGE WITH THE PRESSURE. NO PROBLEM ENCOUNTERED WITH ANOTHER BOX FROM THE SAME BATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1938505 CONNECTA PLUS3 WHITE PEGS STOPCOCK, I.V. SET FMG BECTON DICKINSON 4061448 00382903946013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown