BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD INFUSION SET

    MDR report key: 19391095 · Received May 24, 2024

    Report

    Report Number
    9616066-2024-00790
    Event Type
    Malfunction
    Date Received
    May 24, 2024
    Date of Event
    April 30, 2024
    Report Date
    May 3, 2024
    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
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THE TRI-FUSE LUER LEAKED, AND RETURNED ONE TRIFUSE SET. UPON INITIAL VISUAL EXAMINATION, THE SET(S) HAD NO DEFECTS OR ABNORMALITIES. THE SET WAS INFUSED WITH WATER FROM ALL PORTS, BUT NO CRACK OR LEAKAGE WAS ABLE TO BE FOUND. ALL LUERS WERE IN GOOD WORKING ORDER, AND THE COMPLAINT WAS NOT VERIFIED. THE ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED WITHOUT A REPLICATION OF THE FAILURE. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE MATERIAL AND LOT NUMBER ARE UNKNOWN. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFIED BD INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE BELOW REPORT WAS MADE AT NYU: TRI-FUSE CRACKED AT LEUR LOCK, LEAKING ALL OVER BED. NEEDLESS ACCESS VALVE CHANGED, NEW TRI-FUSE PRIMED AND RE-ATTACHED. THE LOT NUMBER IS UNKNOWN, BUT THE ITEM WAS SEQUESTERED FOR QUALITY REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2273734 UNSPECIFIED BD INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown