BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FEMALE LL ADAPTOR

    MDR report key: 18932470 · Received March 19, 2024

    Report

    Report Number
    9616066-2024-00426
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Date of Event
    February 14, 2024
    Report Date
    March 22, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    70885403484348
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DHR. PHOTO ONLY: NO TRUE DEVICE EVALUATION. THE CUSTOMER REPORTED CRACKS IN FEMALE LUER LOCK, AND RETURNED PHOTOS. THE INVESTIGATION COULD NOT BE CONFIRMED WITHOUT THE PHYSICAL SAMPLES. CURRENTLY, THE DEFECT HAS NOT BEEN REPORTED IN ANY CAPACITY AT NAMC. THE ROOT CAUSE COULD NOT BE DETERMINED UNTIL THE SAMPLES ARE PROVIDED TO NAMC FOR FURTHER INVESTIGATION. NAMC PERFORMED A DEVICE HISTORY RECORD (DHR) REVIEW ON BATCH#S: 2025522, 2208760, 2208761, 1132642, 317918 FOR COMPONENT 1024-156-043, WHICH INCLUDES ALL DATA COLLECTED DURING IN PROCESS AND QUALITY INSPECTIONS. THE BATCHES INVOLVED IN THIS COMPLAINT MEET ALL ACCEPTABLE QUALITY LEVELS (AQL'S), WERE MANUFACTURED, AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. QN QUERY FOR THE CRACKS CONDITION WAS PERFORMED IN ALL THE AFFECTED BATCHES, AND NO HISTORY OF THE DEFECT WAS DETECTED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D4. MEDICAL DEVICE LOT #: 2025522. H4. DEVICE MANUFACTURE DATE: 25/JAN/2022. D4. MEDICAL DEVICE LOT #: 2208760. H4. DEVICE MANUFACTURE DATE:27/JUL/2022. D4. MEDICAL DEVICE LOT #: 2208761. H4. DEVICE MANUFACTURE DATE: 27/JUL/2022. D4. MEDICAL DEVICE LOT #: 1132642. H4. DEVICE MANUFACTURE DATE: 12/MAY/2022. D4. MEDICAL DEVICE LOT #: 0317918. H4. DEVICE MANUFACTURE DATE:12/NOV/2022. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD FEMALE LL ADAPTOR WAS CRACKED . THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT CRACKS. THE INTENT OF THIS EMAIL IS TO NOTIFY ICU MEDICAL RECEIVED SEVERAL CUSTOMER COMPLAINTS FOR CRACKS THE FOLLOWING LOTS: 2025522; 2208760; 2208761; 1132642; 317918; 2017612.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2277533 BD FEMALE LL ADAPTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. SEE H.10 70885403484348

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown