BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN 3ML SFTY COMBO 25X1

    MDR report key: 9450736 · Received December 11, 2019

    Report

    Report Number
    1017768-2019-00749
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Date of Event
    November 20, 2019
    Report Date
    March 9, 2020
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    UDI-DI
    10884521005839
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY-PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. SPECIFICALLY, ALL LOTS ARE EXAMINED FOR CORRECT ASSEMBLY AND PACKAGING. THE LOT MET ALL DEFINED ACCEPTANCE REQUIREMENTS AND WAS RELEASED. ONE (1) OPENED SAMPLE WITH LOT NUMBER 820834 HAS THE NEEDLE SUBASSEMBLY INSIDE OF THE PACKAGING WITH THE BARREL SEPARATED FROM THE PACKAGING AND NEEDLE SUBASSEMBLY. THE PICTURE PROVIDED WITH THE COMPLAINT RECORD OF THE OPENED SAMPLE IN THE KIT ALSO SHOWS THAT THE LUER TAPER TIP ON THE BARREL WAS NOT FULLY ENGAGED WITH THE LUER LOCK HUB ON THE NEEDLE SUBASSEMBLY. THEREFORE, THE REPORTED CONDITION IS CONFIRMED. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION. THE INVESTIGATION DID NOT IDENTIFY A SYSTEMIC ISSUE WITH THE PRODUCT OR PROCESS. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS NOT NECESSARY AT THIS TIME. THIS INFORMATION WILL BE UTILIZED FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE NEEDLE WAS IMPROPERLY ATTACHED TO THE LUER OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246730 MAGELLAN 3ML SFTY COMBO 25X1 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 8881833510 820834 10884521005839

    Patients

    Seq Age Sex Outcome Treatment
    1