BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXELINT 1ML DISPOSABLE SYRINGE

    MDR report key: 2132630 · Received June 10, 2011

    Report

    Report Number
    MW5020985
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 10, 2011
    Manufacturer
    EXELINT INTERNATIONAL CO.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AS NURSE EMPLOYED IN A DOCTORS OFFICE, OPENED NEW SYRINGE PACKAGING FOR INJECTION NOTICED 'HAZE' NEAR SYRINGE PLUNGER, CAREFUL INSPECTION SHOWS 'HAZE' APPEARS TO BE LINT CONTAINED WITHIN SYRINGE. SYRINGES PURCHASED AT (B)(4) SUPPLY COMPANY: 1ML SYRINGE, REF (B)(4), MODEL 1ML LUER SLIP TIP W/25G X 5/8" LOT #100401. SYRINGE WAS NOT USED AND RETAINED FOR FUTURE INSPECTION. PRODUCT WAS NOT USED ON PT NOR WAS MEDICATION VIAL THAT WAS ASPIRATED FROM. SIMPLY HAVE CONCERN THAT PARTICULATE CONTAMINATION WAS CONTAINED WITH IN SYRINGE AND POSSIBLY A MANUFACTURING ISSUE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXELINT 1ML DISPOSABLE SYRINGE 1ML LUER SLIP TIP W/25G X 5/5" FMF EXELINT INTERNATIONAL CO. 1 ML LUER SLIP TIP 100401

    Patients

    Seq Age Sex Outcome Treatment
    1