BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD

    MDR report key: 2142467 · Received June 22, 2011

    Report

    Report Number
    MW5021129
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 22, 2011
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PURCHASED LOT 9138477 C FROM (B)(6). ORDERED 100 COUNT, SHIPPED 1 BOX OF 90 COUNT IN 10X9 BAGS AND SEPARATE 1X10 BAG WITHOUT INCLUDING INSERT OR ORIGINAL BOX. BAG MAY BE COMPROMISED IN SHIPPING AND MAY NO LONGER BE STERILE AS EVIDENT OF AIR LEAKING INTO AND OUT OF BAG. CATALOG 328279 INDICATES "MAIL ORDER." SYRINGE IS INSULIN SYRINGE. PRODUCT NOT USED, COMPLAINT TO (B)(6) PHARMACY AND NO RESOLUTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD INSULIN SYRINGE 30G 12.7 MM FMF 328279 9138477 C

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR