BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NORMAL SALINE I.V. FLUSH SYRINGE, 0.9% NACL, PRESERVATIVE FREE

    MDR report key: 4046875 · Received August 15, 2014

    Report

    Report Number
    MW5037944
    Event Type
    Injury
    Date Received
    August 15, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 13, 2014
    Manufacturer
    MEDEFIL INC.
    Product Code
    NGT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTS METALIC TASTE AND NAUSEA AFTER IV FLUSH WITH NORMAL SALINE PRESERVATIVE FLUSH. MEDEFIL INC, (B)(4) NORMAL SALINE I.V. FLUSH SYRINGE 10ML FILL WITH 12ML SYRINGE LL RX ONLY. NDC 64253-0111-30. POTENTIAL LOT # S14313/MAY 2016. UPON USING REGULAR NORMAL SALINE (HOSPIRA) IV VIALS PRESERVATIVE FREE, PATIENT DID NOT HAVE SIMILAR REACTION. PT EXPERIENCES NAUSEA WITH VOMITING AFTER RECEIVING IMMEDIATELY FROM PRE FILLED SYRINGE WITH NORMAL SALINE. NO PROBLEM WITH GIVE/NORMAL SALINE FROM VIALS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491744 NORMAL SALINE I.V. FLUSH SYRINGE, 0.9% NACL, PRESERVATIVE FREE NORMAL SALINE I.V. FLUSH SYRINGE, PRESERVATIVE FREE NGT MEDEFIL INC. 64253-0111-30 POTENTIAL: S14313

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR