BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN 3ML SFTY COMBO 25X1

    MDR report key: 9458243 · Received December 12, 2019

    Report

    Report Number
    1017768-2019-00750
    Event Type
    Malfunction
    Date Received
    December 12, 2019
    Date of Event
    November 15, 2019
    Report Date
    March 10, 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 FOR THE REPORTED LOT # 821918 AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. REPRESENTATIVE SAMPLES HAVE BEEN RECEIVED WITH THIS COMPLAINT RECORD WITH LOT NUMBERS 820834, 826105 AND 820833. THE DEVICE HISTORY RECORD FOR THE LOT NUMBERS 820834, 826105 AND 820833 WAS REVIEWED, AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. FIVE (5) SAMPLES (1 SAMPLE FROM LOT NUMBER 820834, 2 SAMPLES FROM LOT NUMBER 820833, AND 2 SAMPLES FROM LOT NUMBER 826105) WERE RETURNED TO THE MANUFACTURING PLANT AS A REPRESENTATIVE SAMPLE. ALL 5 SAMPLES HAD THE SAFETY SHIELD IN THE CORRECT POSITION AS THEY ARE PACKAGED. THE REPORTED CONDITION OF A SAFETY SHIELD ISSUE COULD NOT BE CONFIRMED. A REVIEW OF MAINTENANCE RECORDS (BOTH CORRECTIVE AND PREVENTIVE) AND CALIBRATION RECORDS WERE REVIEWED AND THERE WERE NO ISSUES. ALL SCHEDULED MAINTENANCE AND CALIBRATION ACTIVITIES WERE COMPLETED. THERE WERE NO RELATED PROCESS OR MATERIAL CHANGES RELATED TO THE REPORTED CONDITION FOR THIS PRODUCT. THE PROCESS MONITORING DATA WAS REVIEWED FOR THE ASSEMBLY EQUIPMENT AND THERE WERE NO ISSUES RELATED TO THE REPORTED CONDITION. A REVIEW OF THE MACHINE SETUP WAS CONDUCTED AND THERE WERE NO ISSUES. A REVIEW OF THE MANUFACTURING EQUIPMENT WAS PERFORMED AS PART OF THIS INVESTIGATION. THE REVIEW FOUND NO ISSUES WITH THE EQUIPMENT OR PROCESS RELATED TO THE REPORTED CONDITION. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED AS THE REPORTED CONDITION WAS NOT CONFIRMED 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 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 THE TIP WAS NOT ATTACHED PROPERLY AND FELL OFF. ADDITIONAL INFORMATION PROVIDED ON 04-DEC-2019 STATED THE TIP WAS REFERRING TO THE NEEDLE NOT BEING ATTACHED TO THE SYRINGE. THE ISSUE WAS NOTICED BEFORE USE AND THERE WAS NO PATIENT/STAFF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254899 MAGELLAN 3ML SFTY COMBO 25X1 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 8881833510 821918 10884521005839

    Patients

    Seq Age Sex Outcome Treatment
    1