BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ML BBL SHORT REG WOS UPT 3622

    MDR report key: 10392887 · Received August 11, 2020

    Report

    Report Number
    1915484-2020-01180
    Event Type
    Malfunction
    Date Received
    August 11, 2020
    Date of Event
    July 17, 2020
    Report Date
    September 10, 2020
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. TWENTY-ONE BARRELS WERE RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION. A COMPLETE INVESTIGATION WAS PERFORMED. VISUAL INSPECTION TO THE QUALITY INSPECTION STANDARD WAS CONDUCTED. FLASH WAS IDENTIFIED ON THE SYRINGE TIPS OF ALL SYRINGE BARRELS RECEIVED. THE SYRINGE BARRELS WERE SUBMITTED TO THE METROLOGY LAB TO MEASURE THE FLASH TO ASSESS WHETHER THE FLASH WAS WITHIN SPECIFICATION. THERE WERE 0 ISSUES CONFIRMED PER THE QIS. 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. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS EXCESS PLASTIC/FLASH ON THE LUER NIBS CAUSING FITTING ISSUES WHEN THE TUBES ARE FITTED INTO FIXTURES. THE EXCESS COMES AWAY DURING APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857651 1ML BBL SHORT REG WOS UPT 3622 SYRINGE, PISTON FMF COVIDIEN 5551771010 015335X

    Patients

    Seq Age Sex Outcome Treatment
    1