BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTACT DETACH

    MDR report key: 25180968 · Received May 15, 2026

    Report

    Report Number
    3003442380-2026-17453
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 10, 2026
    Report Date
    April 15, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A DE C.V
    Product Code
    FPA
    UDI-DI
    05705244025288
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NAME: BETA BIONICS INC. COUNTRY: UNITED STATES OF AMERICA. ADDRESS ¿ LINE 1: 8 SAINT MARY¿S STREET. CITY: BOSTON. STATE: MA. ZIP CODE: 91325 ¿ 1219 . BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER. REPORTING SITE: 8021545. MANUFACTURING SITE: 3003442380.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ADHESIVE DETACHED DUE TO TUBING BECOMING SNAGGED AND BEING INADVERTENTLY REMOVED ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518199 CONTACT DETACH SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL DEVICES S.A DE C.V FG000016-03 6015437 05705244025288

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Unknown