BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEPARIN LOCK FLUSH

    MDR report key: 2643146 · Received June 27, 2012

    Report

    Report Number
    MW5026008
    Event Type
    Malfunction
    Date Received
    June 27, 2012
    Date of Event
    June 26, 2012
    Report Date
    June 27, 2012
    Manufacturer
    APP
    Product Code
    NZW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    TODAY ONE OF OUR PHYSICIANS WAS TRYING TO GET A BONE MARROW BIOPSY ON ONE OF OUR PTS. THEY FOLLOWED THEIR NORMAL PROCEDURE THREE TIMES (DRAWING HEPARIN INTO THE SYRINGE TO COAT THE INSIDE BEFORE GETTING THE BIOPSY) AND ALL THREE TIMES, IT CLOTTED. THIS OCCURRED WITH 2 VIALS OF HEPARIN THAT HAPPEN TO HAVE THE SAME LOT NUMBERS. ALSO, THIS PT TYPICALLY HAS LOW PLATELETS. SINCE THIS IS A PRETTY UNCOMMON OCCURRENCE THEY ARE WONDERING IF THERE HAS BEEN ANY RECALLS OR IF THERE IS ANY INFO AVAILABLE THAT MIGHT SHINE MORE LIGHT ON THE ISSUE. AT THE VERY LEAST, A REPORT MIGHT BE IN ORDER. HEPARIN 100 U/ML 5 ML VIALS, NDC (B)(4), LOT 6003651, EXP 3/15. REASON FOR USE: COAT INSIDE OF SYRINGE PRIOR TO GETTING BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEPARIN LOCK FLUSH HEPARIN LOCK FLUSH 5 ML VIAL 100 U PER ML NZW APP 6003651

    Patients

    Seq Age Sex Outcome Treatment
    1 Other