BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEPARIN LOCK FLUSH USP, 50 UPS UNITS PER 5 ML, 5 ML IN 10 ML FLUSH ZR

    MDR report key: 19373201 · Received May 21, 2024

    Report

    Report Number
    MW5155204
    Event Type
    Injury
    Date Received
    May 21, 2024
    Date of Event
    May 17, 2024
    Report Date
    May 18, 2024
    Manufacturer
    EXCELSIOR MEDICAL LLC
    Product Code
    NZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DURING THE PROCEDURE FOR FLUSHING A CENTRAL LINE WITH HEPARIN, PATIENT EXPERIENCED SULPHURIC TASTE, LOW BLOOD PRESSURE/ LIGHTHEADED. REVIEWED HEPARIN SOURCES AND THERE WAS A CHANGE FROM BD TO EXCELSIOR MEDICAL. BD SAYS MADE IN THE USA. EXCELSIOR SAYS MADE IN USA FROM IMPORTED AND DOMESTIC MATERIALS. HEPARIN IS SUPPLIED BY (B)(4). PHONE (B)(6). LOT NUMBER OF FLUSHES IS 3143185, EMZ50051240. PATIENT HAS A CLOTTING DISORDER AT RISK FOR ANY CHANGE IN THE CLOTTING CASCADE. PATIENT TAKES PRADAXA 2X DAY AS BLOOD THINNER. CBC IS USUALLY IN RANGE WITHOUT BEING HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2305030 HEPARIN LOCK FLUSH USP, 50 UPS UNITS PER 5 ML, 5 ML IN 10 ML FLUSH ZR HEPARIN, VASCULAR ACCESS FLUSH NZW EXCELSIOR MEDICAL LLC EMZ50051240 3143185

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Other| L