BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN 3ML SFTY COMBO 23X1

    MDR report key: 15476531 · Received September 24, 2022

    Report

    Report Number
    1017768-2022-01024
    Event Type
    Malfunction
    Date Received
    September 24, 2022
    Date of Event
    August 22, 2022
    Report Date
    November 2, 2022
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FMF
    UDI-DI
    10192253024739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES WERE NOT RECEIVED FOR THE INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE REPORTED ISSUE AND DETERMINE A ROOT CAUSE. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. FUNCTIONAL TESTING AND VISUAL INSPECTIONS ARE BEING PERFORMED ACCORDING TO OUR CURRENT QUALITY STANDARDS AND INSPECTION PROCEDURES. IF A SAMPLE IS RECEIVED AT A LATER DATE, THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION SUMMARY WAS SENT TO THE QRA INBOX FOR TRANSLATION AND ONCE TRANSLATED, THE REGION WILL ATTACH THE CLOSURE LETTER.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING IM MEDICATION ADMINISTRATION (LASIX), LIQUID MEDICATION SPRAYED OUT OF NEEDLE HUB. NEEDLE HUB FOUND TO BE CRACKED UPON INSPECTION. UNSURE OF HOW MUCH MEDICATION PATIENT ACTUALLY RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1652566 MAGELLAN 3ML SFTY COMBO 23X1 SYRINGE, PISTON FMF CARDINAL HEALTH 8881833310 202434 10192253024739

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female