BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRE FILLED SALINE SYRINGE

    MDR report key: 1202335 · Received October 16, 2008

    Report

    Report Number
    MW5008642
    Event Type
    Other
    Date Received
    October 16, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 16, 2008
    Manufacturer
    AMSINO MEDICAL USA
    Product Code
    NGT
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    AS I WAS FLUSHING MY SON'S CENTRAL LINE WITH PRE-FILLED SALINE SYRINGES, I NOTICED ONE OF THE SYRINGES DID NOT CONTAIN ANY SALINE. IT WAS PERFECTLY DRY. I WAS LUCKY THAT I NOTICED IT BEFORE I USED IT. I DID LEAVE A MESSAGE FOR THE QUALITY CONTROL DEPARTMENT AND ALSO MY HOMECARE COMPANY. I HAVE NOT HEARD BACK AT THIS TIME. DOSE OR AMOUNT: 5ML. FREQUENCY: DAILY. ROUTE: IV. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: REMOVAL OF SMALL INTESTINE. EVENT ABATED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRE FILLED SALINE SYRINGE 0.09% SODIUM CHLORIDE NGT AMSINO MEDICAL USA 2K0905 KH02721

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR