BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN 3ML SFTY COMBO 25X1

    MDR report key: 9808338 · Received March 9, 2020

    Report

    Report Number
    1017768-2020-00809
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Report Date
    April 16, 2020
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    UDI-DI
    10884521000568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION D 4: LOT NUMBER CORRECTED DUE TO SAMPLE EVALUATION. H 3 SAMPLE EVALUATION THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER INDICATES THAT NO ISSUES WERE FOUND IN VISUAL AND PHYSICAL SAMPLES INSPECTED. THE LOT NUMBER WAS WRITTEN INCORRECTLY IN THE COMPLAINT AS THE LOT NUMBER ON THE SAMPLE RETURNED IS 902844, NOT 902884. THERE WAS 1 SAMPLE RETURNED FOR EVALUATION. THERE WERE ALSO PICTURES PROVIDED SHOWING THE STRING FLASH COMING FROM THE GAIT ON THE SAFETY SHIELD. THE REPORTED CONDITION IS CONFIRMED THROUGH THE SAMPLE EVALUATION AND PHOTOS. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION AND THERE WERE NO RELATED ISSUES FOUND IN A REVIEW OF MANUFACTURING RECORDS. THERE WAS NO INDICATION OF A SYSTEMIC ISSUE WITH THE PROCESS OR PRODUCTION. BASED ON AVAILABLE INFORMATION, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A MAGELLAN NEEDLE WITH A FIBER LOCATED ON THE OUTSIDE OF THE NEEDLE CONNECTING TO SAFETY MECHANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269869 MAGELLAN 3ML SFTY COMBO 25X1 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 8881850510 902844 10884521000568

    Patients

    Seq Age Sex Outcome Treatment
    1