BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTEC GRIPPER PLUS NEEDLES

    MDR report key: 24303085 · Received February 10, 2026

    Report

    Report Number
    3012307300-2026-01095
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    January 20, 2026
    Report Date
    April 27, 2026
    Manufacturer
    ICU MEDICAL MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10610586027697
    PMA / PMN Number
    K021999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILLED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    PHOTOS WERE RECEIVED FOR EVALUATION FOR THE COMPLAINT THAT A DROP-BY-DROP LEAKAGE AT THE LEVEL OF THE GRIPPER VALVE. THE PHOTOS RECEIVED THE DEFECT WAS NOT POSSIBLE TO CONFIRM, SAMPLES AND LOT NUMBER WAS NOT RECEIVED, THEREFORE THE CORRESPONDING TEST COULD NOT BE POSSIBLE TO CONFIRM, IN CASE TO RECEIVE THE LOT AND THE SAMPLE, THE COMPLAINT WILL BE RE-OPEN FOR PERFORM THE CORRESPONDING EVALUATION.

    Description of Event or Problem · 0

    IT WAS STATED THAT THERE WAS AN EQUIPMENT MALFUNCTION ENCOUNTERED IN THE ONCOLOGY DAY HOSPITAL (HDJ) DURING A CHEMOTHERAPY SESSION. THE NURSE NOTICED A DROP-BY-DROP LEAKAGE AT THE LEVEL OF THE GRIPPER VALVE. FURTHER ON, IT WAS NOTICED THAT THE CHEMOTHERAPY SOLUTION LEAKED ONTO THE PATIENT¿S CLOTHING. THE INFUSION WAS STOPPED AND THE PATIENT¿S SKIN WAS DECONTAMINATED. AT THAT TIME, NO SKIN REACTION HAS BEEN OBSERVED. THE PATIENT WAS SEEN AGAIN, THE NEXT DAY FOR SKIN DECONTAMINATION. THERE WAS PATIENT INVOLVEMENT AND NO CLINICAL CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548 DELTEC GRIPPER PLUS NEEDLES SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL MANUFACTURING S.A. DE C.V. UNKNOWN 10610586027697

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown