BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET

    MDR report key: 25168754 · Received May 14, 2026

    Report

    Report Number
    3003442380-2026-17454
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 2, 2026
    Report Date
    April 15, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A DE C.V
    Product Code
    FPA
    UDI-DI
    05705244025202
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. ADDRESS ¿ LINE 2: SUITE 936. CITY: BOSTON. STATE: MASSACHUSETTS. ZIP CODE: 02215 ¿ 2421. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. REQUEST WAS PERFORMED FOR ADDITIONAL INFORMATION INCLUDING LOT NUMBER; HOWEVER, LOT NUMBER WAS NOT PROVIDED. A COMPLAINT INVESTIGATION WAS INITIATED UNDER COMPLAINT INVESTIGATION. UNFORTUNATELY, NO SPECIFIC LOT NUMBER WAS IDENTIFIED, WHICH LIMITS THE ABILITY TO TRACE OR ANALYZE A PARTICULAR ITEM. INVESTIGATION IN PROGRESS. 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 WAS COMPROMISED WHEN THE TUBING BECAME CAUGHT AND SUBSEQUENTLY PULLED AWAY FROM THE SURFACE ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448312 INSET SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL DEVICES S.A DE C.V FG000016-01 UNKNOWN 05705244025202

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Unknown