BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUEPLUS, 0.5 CC 31 GAUGE SYRINGE

    MDR report key: 6278931 · Received January 24, 2017

    Report

    Report Number
    MW5067450
    Event Type
    Injury
    Date Received
    January 24, 2017
    Date of Event
    January 20, 2017
    Report Date
    January 24, 2017
    Manufacturer
    TRIVIDIA HEALTH
    Product Code
    FMF
    UDI-DI
    56151173201
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    TRUEPLUS 0.5 CC INSULIN SYRINGES CONTAIN MOISTURE IN THE UNOPENED SYRINGE. THE COMPANY AGREED TO REPLACE THEM. TRUEPLUS INSULIN SYRINGES 56151-1732-01 0.5 CC 31 GAUGE SYRINGES EXP 02/18/2019. LOT: NP16030. (B)(6) 2016 - (B)(6) 2017, UNOPENED SYRINGES CONTAIN VISIBLE MOISTURE/LIQUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56864 TRUEPLUS, 0.5 CC 31 GAUGE SYRINGE INSULIN SYRINGE FMF TRIVIDIA HEALTH NP16030 56151173201

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention