BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12CC LUER LOCK PHAMARCY TRAY 25S

    MDR report key: 6025539 · Received October 13, 2016

    Report

    Report Number
    9612030-2016-00510
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    July 13, 2016
    Report Date
    July 13, 2016
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 10/13/2016. ADDITIONAL INFORMATION WAS PROVIDED BY A MEDTRONIC SALES REPRESENTATIVE ON 10/13/2016 CONFIRMING THAT THIS IS A DUPLICATE OF A PREVIOUSLY REPORTED COMPLAINT MFR REPORT# 9612030-2016-00333. THEREFORE THIS COMPLAINT WILL BE VOIDED AND NO ADDITIONAL INVESTIGATION RESULTS WILL BE SENT.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 10/13/2016. AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A SYRINGE. CUSTOMER REPORTS THAT 1 TO 2 SYRINGES IN EACH TRAY ARE CLOUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679939 12CC LUER LOCK PHAMARCY TRAY 25S SYRINGE FMF COVIDIEN 8881512258 614581464X

    Patients

    Seq Age Sex Outcome Treatment
    1