BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT

    MDR report key: 7263128 · Received February 12, 2018

    Report

    Report Number
    1282497-2018-00099
    Event Type
    Malfunction
    Date Received
    February 12, 2018
    Date of Event
    January 26, 2018
    Report Date
    September 6, 2018
    Manufacturer
    COVIDIEN
    Product Code
    NGT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 2/12/2018. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    SUBMISSION DATE: 09/06/2018 AN INVESTIGATION WAS PERFORMED FOR THE REPORTED CUSTOMER COMPLAINT: ¿THE CUSTOMER REPORTED THAT BLOOD WAS LEAKING FROM THE NEEDLE AND SYRINGE.¿ A REVIEW OF THE DEVICE HISTORY RECORD (DHR) OF THE REPORTED LOT NUMBER 3131606 INDICATES THAT PRODUCT AND SPECIFICATION REQUIREMENTS WERE MET WITH NO NON-CONFORMING PRODUCT IDENTIFIED RELATING TO THIS CUSTOMER REPORT. DURING THE MANUFACTURING OF THE SYRINGE ASSEMBLIES, SYRINGES WERE VISUALLY INSPECTED AND PHYSICALLY TESTED. NO DEFICIENCIES WERE RECORDED RELATING TO THIS CUSTOMER REPORT. CONTROL MECHANISMS ARE IN PLACE TO PREVENT THE OCCURRENCE AND ACCEPTANCE OF DAMAGED SYRINGES OR SYRINGES WHICH LEAK DURING THE SYRINGE MOLDING, ASSEMBLY AND PACKAGING PROCESSES. THESE INCLUDE, BUT ARE NOT LIMITED TO: MATERIAL VERIFICATION/CERTIFICATION PROCESSES, DIMENSIONAL SPECIFICATIONS, MACHINE MAINTENANCE REQUIREMENTS, AND PERSONNEL TRAINING AND CERTIFICATION. A LOT CANNOT BE RELEASED UNLESS IT PASSES ALL VISUAL AND PHYSICAL TESTING REQUIREMENTS. THIS PRODUCT WAS BEING USED FOR TREATMENT OR DIAGNOSIS. ONE (1) SAMPLE WAS RECEIVED AND A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED BY THE SUPPLIER. INSPECTION OF THE SAMPLE FOUND THAT THE FAILURE OCCURRED BETWEEN THE NEEDLE TIP AND THE EXTENSION SET AND NOT THE SYRINGE LUER. THE CUSTOMER REPORTED THE LEAKAGE OCCURRED AT THE SYRINGE LUER. THEREFORE, THE REPORTED COMPLAINT WAS UNABLE TO BE CONFIRMED. THE REPORTED CUSTOMER COMPLAINT IS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. THIS COMPLAINT WILL BE UTILIZED FOR TRACKING AND TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT BLOOD WAS LEAKING FROM THE NEEDLE AND SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106241 MONOJECT SALINE, VASCULAR ACCESS FLUSH NGT COVIDIEN 8881579121 3131606

    Patients

    Seq Age Sex Outcome Treatment
    1