BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSEMBLY FIXTURE M12

    MDR report key: 11478707 · Received March 14, 2021

    Report

    Report Number
    3003152976-2021-00137
    Event Type
    Malfunction
    Date Received
    March 14, 2021
    Date of Event
    February 15, 2021
    Report Date
    May 10, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT#: 1910002, 1910003. H.6. INVESTIGATION: THREE FIXTURES AND ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION OF THE PHOTO, THE LABEL DISPLAYS ITEM 515400 M12 ASSEMBLY FIXTURE AND THE PRODUCT WITHIN WAS CONFIRMED TO BE ITEM 515400. TWO ADDITIONAL FIXTURES WERE RECEIVED IN AN ALTERNATE PACKAGE, HOWEVER, BOTH FIXTURES WERE VERIFIED TO BE ITEM 515400. A REVIEW OF DEVICE RECORDS WAS PERFORMED FOR LOTS 1910003 AND 1910002, ALL PRODUCT WAS VERIFIED TO BE MANUFACTURED ACCORDING TO SPECIFICATION. PRODUCT UNDERGOES 100% INSPECTION BEFORE RELEASE, INCLUDING VERIFICATION OF THE PROPER PRODUCT LABELING, NO ISSUES WERE IDENTIFIED RELATED TO THE REPORTED ISSUE. BASED ON OUR QUALITY TEAM'S INVESTIGATION AND THE SAMPLE EVALUATION, NO PRODUCT DEFECT WAS IDENTIFIED AS THE CASE LABELING AND PRODUCT WITHIN WAS VERIFIED TO BE ITEM 515400. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 ASSEMBLY FIXTURES M12 WERE MIXED WITH INCORRECT PRODUCT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TWO TIME THE CUSTOMER HAS RECEIVED A WRONG PRODUCT."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 ASSEMBLY FIXTURES M12 WERE MIXED WITH INCORRECT PRODUCT.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TWO TIME THE CUSTOMER HAS RECEIVED A WRONG PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375701 ASSEMBLY FIXTURE M12 INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1