BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10ML STERILE LUER-LOCK SYRINGES

    MDR report key: 3111472 · Received May 8, 2013

    Report

    Report Number
    MW5030111
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 25, 2013
    Manufacturer
    BD
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    QUALITY ISSUE - CONTAMINATION. PHYSICAL CONTAMINATION OBSERVED INSIDE A "STERILE" TRAY OF 10ML BD SYRINGES. THE TRAY WAS OPENED INSIDE AN ISO CLASS 5 AREA. DATES OF USE: (B)(6) 2013,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202308 10ML STERILE LUER-LOCK SYRINGES 10ML STERILE LUER-LOCK SYRINGES FMF BD NA 3001165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA