BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FEMALE LUER-LOK ADAPTER

    MDR report key: 16067426 · Received December 29, 2022

    Report

    Report Number
    9616066-2022-02092
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    December 8, 2022
    Report Date
    January 6, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    70885403484188
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A COMPLAINT OF ADAPTORS BEING RECEIVED WITH DIRT ON THEM WAS REPORTED BY THE CUSTOMER. PHOTOS WERE PROVIDED BY THE CUSTOMER THAT SHOW THE PRODUCT. FOREIGN MATTER COULD NOT BE SEEN IN THE PHOTO. A DEVICE HISTORY REVIEW WAS PERFORMED FOR PART 1022-156-032. FROM THE DHR REVIEW OF LOT NO. 2256443, THERE WAS NO RECORDED ACTIVITY ASSOCIATED WITH THIS CONDITION. ADDITIONALLY, THERE WERE 13 IN-PROCESS INSPECTIONS PERFORMED THAT TOTALED 832 TOTAL PARTS INSPECTED WITH 0 DEFECTS NOTED FOR BATCH NUMBER 2256443. THE COMPLAINT CANNOT BE CONFIRMED AS THE IMAGE PROVIDED DOES NOT DISPLAY ANY FOREIGN MATTER, AND PHYSICAL SAMPLES HAVE NOT BEEN PROVIDED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 OF THE BD FEMALE LUER-LOK ADAPTER HAD FOREIGN MATTER IN FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE PURPOSE OF THIS EMAIL IS TO NOTIFY US THAT OUR PRODUCTION TEAM REPORTED 6 PIECES WITH THE FEMALE LUER WITH DIRT LIKE SHOWN IN THE PHOTO BELOW, THE TOTAL ORDER WAS PROCESSED, SO WE ONLY NEED YOU TO HELP US TAKE CORRECTIVE ACTIONS SUCH AS CHECKING INVENTORIES, ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 OF THE BD FEMALE LUER-LOK ADAPTER HAD FOREIGN MATTER IN FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE PURPOSE OF THIS EMAIL IS TO NOTIFY US THAT OUR PRODUCTION TEAM REPORTED 6 PIECES WITH THE FEMALE LUER WITH DIRT, THE TOTAL ORDER WAS PROCESSED, SO WE ONLY NEED YOU TO HELP US TAKE CORRECTIVE ACTIONS SUCH AS CHECKING INVENTORIES, ROOT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471449 BD FEMALE LUER-LOK ADAPTER INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 2256443 70885403484188

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown