BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FEMALE LL ADAPTOR

    MDR report key: 20946411 · Received December 16, 2024

    Report

    Report Number
    9616066-2024-02061
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    May 27, 2024
    Report Date
    January 15, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED LEAKAGE AT THE CONNECTION AND RETURNED PHOTOS OF THE ISSUE. THE MATERIAL 1022-091-032 IS MANUFACTURED AT THE BD FACILITY NORTH AMERICA MOLDING CENTER (NAMC), WHO WAS FORWARDED THE INFORMATION AND PHOTOS. THE INVESTIGATION FOUND THAT SINCE NO PHYSICAL SAMPLES WERE PROVIDED, THE DEFECT COULD NOT BE CONFIRMED, AND NO ROOT CAUSE COULD BE DETERMINED FOR THIS OCCURRENCE. IN ADDITION, PREVENTATIVE MAINTENANCE FOR THE MOLD WAS REVIEWED AND ALL SCHEDULED PM ACTIVITIES WERE COMPLETED ON TIME UP TO COMPLETION OF THESE BATCHES. THIS TYPE OF DEFECT WILL CONTINUE TO BE MONITORED PER NAMC¿S IN-PROCESS INSPECTION PLAN. NAMC PERFORMED A DEVICE HISTORY RECORD¿S REVIEW (DHR) INCLUDING A REVIEW OF 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. NO OBSERVATIONS/EVENTS RELATING TO THE COMPLAINT CONDITION WERE FOUND.

    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

    MATERIAL # 1022-091-032. BATCH # 3086646. IT WAS REPORTED BY CUSTOMER THAT THEY RECEIVED COMPLAINTS AT MEDTRONIC FROM FINAL USERS WHERE IT WAS REPORTED A LEAK WHERE THE 1/8" LINE CONNECTS TO THE MANIFOLD ON THE OXYGENATOR. THE LEAK ORIGINATED FROM THE TUBING CONNECTION. THE SAME LEAK APPEARED IN MULTIPLE PACKS. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THIS IS A NOTIFICATION TO INFORM THAT WE RECEIVED COMPLAINTS AT MEDTRONIC FROM FINAL USERS WHERE IT WAS REPORTED A LEAK WHERE THE 1/8" LINE CONNECTS TO THE MANIFOLD ON THE OXYGENATOR. THE LEAK ORIGINATED FROM THE TUBING CONNECTION. THE SAME LEAK APPEARED IN MULTIPLE PACKS. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. PRODUCT NUMBER - 1022-091-03. LOT NUMBER - 3086646.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD FEMALE LL ADAPTOR WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THEY RECEIVED COMPLAINTS AT MEDTRONIC FROM FINAL USERS WHERE IT WAS REPORTED A LEAK WHERE THE 1/8" LINE CONNECTS TO THE MANIFOLD ON THE OXYGENATOR. THE LEAK ORIGINATED FROM THE TUBING CONNECTION. THE SAME LEAK APPEARED IN MULTIPLE PACKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2393167 BD FEMALE LL ADAPTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 3086646

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown