BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMALE LL ADAPTOR

    MDR report key: 11386828 · Received February 26, 2021

    Report

    Report Number
    2243072-2021-00626
    Event Type
    Malfunction
    Date Received
    February 26, 2021
    Date of Event
    January 25, 2021
    Report Date
    February 26, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 #: 0001220875 H.4. DEVICE MANUFACTURE DATE: 3/22/2018 H.6. INVESTIGATION: DHR WAS REVIEWED AND NO QN/DEVIATIONS WERE OBSERVED. ONE SAMPLE OF THE 1023-105-071 (FEMALE LL ADAPTOR) MODEL WAS SHARED BY CUSTOMER, THE SAMPLE WAS INSPECTED AND DURING VISUAL INSPECTION IT WAS OBSERVED A DAMAGE IN ONE SIDE OF THE SAMPLE CONFIRMING THE REPORTED FAILURE MODE. SINCE THE REPORTED MODEL IS SUPPLIER RELATED, A MANUFACTURING INFORMATION WAS REQUESTED, THE SUPPLIER CONDUCTED A DHR REVIEW AND NO ISSUES WERE FOUND DURING THE MANUFACTURING OF THE REPORTED LOT REGARDING TO THE DIRT IN THE COMPONENT AND IT WAS MANUFACTURED ACCORDING WITH SUPPLIER INTERNAL PROCEDURE, SINCE THE MOLD WAS TRANSFERRED AND NO ISSUES WERE FOUND DURING MANUFACTURING, THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINATE. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FEMALE LL ADAPTOR WAS FOUND CRACKED DURING THE INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I AM REPORTING TO YOUR GROUP A COMPLAINT OF A CRACKED FEMALE LL ADAPTER FOUND DURING USE" "FOUND DURING INFUSION OF 5FU."

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FEMALE LL ADAPTOR WAS FOUND CRACKED DURING THE INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I AM REPORTING TO YOUR GROUP A COMPLAINT OF A CRACKED FEMALE LL ADAPTER FOUND DURING USE". "FOUND DURING INFUSION OF 5FU".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281812 FEMALE LL ADAPTOR INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 0001220875

    Patients

    Seq Age Sex Outcome Treatment
    1