BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTEC GRIPPER MICRO NEEDLESS Y-SITE

    MDR report key: 23939634 · Received January 1, 2026

    Report

    Report Number
    3012307300-2026-00013
    Event Type
    Malfunction
    Date Received
    January 1, 2026
    Date of Event
    December 1, 2025
    Report Date
    March 26, 2026
    Manufacturer
    ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED, BUT DAY IS UNKNOWN. H3: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    D9 - DATE RETURNED TO MFG: 2/19/2026. H3 AND H6 CODES - UPDATED. NINETY-ONE (91) NEW DEVICES FROM THE SAME LOT WERE RETURNED FOR INVESTIGATION. DURING THE FUNCTIONAL TESTING, EXECUTED WITH AN AIR FLOW PROCESS FOR 0.400 SECONDS, ALL THE 91 SAMPLES WERE TESTED, WITHOUT ALARMS OR ISSUES DURING THE INSPECTION. THE CUSTOMER REPORTED ISSUE WAS NOT CONFIRMED. RETROSPECTIVE REVIEW WAS PERFORMED TO 21-3271-24 LOT NUMBER 6126203, FOR A PERIOD OF MARCH 2025 TO MARCH 2026 THERE IS NO COMPLAINTS WITH THE SAME LOT NUMBER OR PART NUMBER RELATED TO THIS FAILURE MODE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLOOD OOZED FROM THE NEEDLELESS ACCESS CONNECTOR. THIS OCCURRED DURING PATIENT USE. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1556 DELTEC GRIPPER MICRO NEEDLESS Y-SITE SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. 6126203

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown