BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN

    MDR report key: 24532624 · Received March 6, 2026

    Report

    Report Number
    24532624
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Date of Event
    December 2, 2025
    Report Date
    January 2, 2026
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OUR FACILITY HAS RECEIVED NUMEROUS REPORTS IN REGARDS TO FINDING STRING LIKE OR FUZZY MATERIAL UNDER SAFETY CAP. THIS RAISES CONCERNS FOR STERILITY ISSUES AND CONCERNS JEOPARDIZING PATIENT SAFETY. REPORTS INDICATE THE FOLLOWING: REMOVED SAFETY CAP--*SMALL STRING/FUZZY MATERIAL UNDER SAFETY CAP ON NEEDLE. UPON REMOVING THE NEEDLE CAP, A HAIR-LIKE DEBRIS WAS NOTED TO BE HANGING OFF THE NEEDLE. REPORTS OF NEEDLES BENDING IN PATIENT ARMS AS WELL. FUZZ FOUND ON NEEDLE. MAGELLAN HYPODERMIC SAFETY NEEDLE 25G 1 INCH LOT #24M274 EXP 10/31/27. MAGELLAN :LOT # IS: 24E191; EXP: 2029-03-31. MAGELLAN HYPODERMIC SAFETY NEEDLE 25NGX 1"" (LOT# 24E191, EXP. 2029-03-31. MAGELLAN HYPODERMIC SAFETY NEEDLE 25G X 1" LOT: 123615 EXP: 2026-06-30. 25G X 1" MAGELLAN HYPODERMIC SAFETY NEEDLE. LOT 029325 EXP 2025-08-31. MAGELLAN LOT 02935, EXP. 8/31/25. MAGELLAN LOT NUMBER FOR THE SYRINGE IS 107445X AND IS 29GX1/2" MAGELLAN LOT 724243. MANUFACTURER RESPONSE FOR MAGELLAN HYPODERMIC SYRINGE, MAGELLAN (PER SITE REPORTER), NO RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315910 MAGELLAN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI CARDINAL HEALTH 8881850510 MANY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other