BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ASSEMBLY NAC-Y SITE (0.088 TUBING) OEM

    MDR report key: 21351737 · Received February 10, 2025

    Report

    Report Number
    9616066-2025-00189
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    January 17, 2025
    Report Date
    February 14, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    70885403463657
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULT: NO 8100-027 SAMPLE WAS AVAILABLE FOR INVESTIGATION. THE CUSTOMER STATED THAT THE AFFECTED LOT WAS 22014082 AND THAT LEAKAGE OCCURRED. NO FURTHER INFORMATION OR PHOTOGRAPHS OF THE AFFECTED PRODUCT WERE AVAILABLE TO ASSIST THE INVESTIGATION. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. FURTHER INFORMATION RELATING TO THE SEQUENCE OF EVENTS AND EXACT NATURE OF THE REPORTED INCIDENT WAS NOT PROVIDED. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 22014082 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS AN ISOLATED FEEDBACK WITH NO FURTHER REPORTS OF THIS NATURE AGAINST THE 8100-027 PRODUCT IN THE PAST 12 MONTHS.

    Additional Manufacturer Narrative · 0

    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

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ASSEMBLY NAC-Y SITE (0.088 TUBING) OEM WAS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1625396 BD ASSEMBLY NAC-Y SITE (0.088 TUBING) OEM INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 22014082 70885403463657

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown