BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY NEEDLE 25 X 5 8

    MDR report key: 8552336 · Received April 25, 2019

    Report

    Report Number
    1017768-2019-00629
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Date of Event
    April 5, 2019
    Report Date
    December 4, 2019
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A LOT NUMBER WAS NOT RECEIVED WITH THIS COMPLAINT HOWEVER WE RECEIVED TWO SAMPLES FROM LOT NUMBER 832368 FOR THE INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED FOR LOT NUMBER 832368 AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. 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. A REVIEW OF THE MACHINE SETUP WAS CONDUCTED AND DID NOT IDENTIFY ANY ISSUES. THE EQUIPMENT WAS REVIEWED FOR MALFUNCTIONS OR ISSUES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION, BUT NO SUCH ISSUES WERE OBSERVED DURING THE REVIEW. THERE WERE 2 OPENED SAMPLES RETURNED FOR THIS COMPLAINT. THE SAMPLES WERE VISUALLY INSPECTED, AND NO VISUAL DEFECTS WERE FOUND. ALL RETURNED SAMPLES WERE TESTED FOR LEAKAGE AND ONE SAMPLE WAS CONFIRMED TO LEAK WITH THE OTHER SAMPLE PASSING INSPECTION. THE 6M ROOT CAUSE ANALYSIS DID NOT IDENTIFY ANY ISSUES WITH THE MANUFACTURING PROCESS FOR THE NEEDLES THAT WOULD HAVE CAUSED THIS ISSUE. THERE WAS ONE POTENTIAL ROOT CAUSE IDENTIFIED DURING THE INVESTIGATION PERTAINING TO THE USER (ATTACHMENT METHOD) BUT THERE¿S INSUFFICIENT INFORMATION TO DETERMINE WHETHER THIS FACTOR WAS THE TRUE ROOT CAUSE. 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, SAMPLES ARE INSPECTED FOR LEAKAGE. THE LOT MET THE ACCEPTANCE CRITERIA AND WAS RELEASED. THERE WERE NO MANUFACTURING ISSUES RELATED TO THE COMPLAINT ISSUED FOR THIS LOT AND A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON AVAILABLE INFORMATION. THERE¿S NO INDICATION OF A SYSTEMIC ISSUE WITH THE PRODUCT OR PROCESS, SO A CORRECTIVE ACTION WILL NOT BE ISSUED AT THIS TIME. THIS INFORMATION WILL BE UTILIZED FOR TRENDING PURPOSES TO DETERMINE THE NEED FOR CORRECTIVE ACTIONS.

    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

    ACCORDING TO THE INITIAL REPORTER, DRUG LEAKS WHERE THE NEEDLE SCREWS INTO THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346297 SAFETY NEEDLE 25 X 5 8 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 8881850558 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1