BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSURE

    MDR report key: 1526740 · Received November 12, 2009

    Report

    Report Number
    1039144-2009-00018
    Event Type
    Malfunction
    Date Received
    November 12, 2009
    Report Date
    November 12, 2009
    Manufacturer
    SHIN CHANG MEDICAL CO., LTD.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE SYRINGES WERE PACKAGED WRONG. THEY HAD THE WRONG NEEDLES, AND THERE WERE 80 SYRINGES INSTEAD OF 100. THE SYRINGES WERE PURCHASED AS 30 GAUGE 1 CC SYRINGES AND WHEN OPENED, THEY WERE 30 GAUGE 1/2 CC SYRINGES. THIS PACKAGE WAS MISLABELED DUE TO THE CONSUMER PURCHASING 30 GAUGE 1 CC SYRINGES AND REC'D 30 GAUGE 1/2 CC INSTEAD. THE CONSUMER ALSO REC'D THE WRONG AMOUNT OF SYRINGES. THEIR PURCHASE WAS FOR 100 SYRINGES AND INSTEAD THEY REC'D ONLY 80 SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSURE INSULIN SYRINGE FMF SHIN CHANG MEDICAL CO., LTD. 30 G - 1 CC SD0314

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK