BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN

    MDR report key: 17689704 · Received September 6, 2023

    Report

    Report Number
    1017768-2023-01089
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Date of Event
    August 17, 2023
    Report Date
    August 28, 2024
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    FMI
    UDI-DI
    10884521000568
    PMA / PMN Number
    K012736
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 0

    AN UNUSED SAMPLE WAS RECEIVED AT THE PLANT FOR THE INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. UPON EVALUATION OF THE SAMPLE, THE REPORTED ISSUE WAS CONFIRMED; THE HUB WAS CRACKED/BROKEN. BASED ON THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. THE FOLLOWING SECTIONS WERE CORRECTED OR COMPLETED: SECTION D1 BRAND NAME: MAGELLAN. SECTION D3 MANUFACTURER NAME: CARDINAL HEALTH, INC. SECTION D4 UNIQUE IDENTIFIER (UDI) #: (B)(4). SECTION G4 PMA/510(K)NUMBER: K012736.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE ITEM CRACKED AT THE BASE SPILLING MEDICINE. PER ADDITIONAL INFORMATION RECEIVED, THE MEDICATION WAS A PNEUMOCOCCAL VACCINE. THEY REPLACED THE ITEM AND WAS ABLE TO DELIVER THE VACCINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2155785 MAGELLAN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI CARDINAL HEALTH, INC. 8881850510 203873 10884521000568

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown