BEUDAMED
    FDA Adverse Event Summary report: N

    HEP-LOCK

    MDR report key: 380948 · Received February 28, 2002

    Report

    Report Number
    MW4003196
    Date Received
    February 28, 2002
    Report Date
    February 25, 2002
    Manufacturer
    WYETH-AYERST LABORATORIES
    Product Code
    FMF
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE MEDICATION ERROR REPORTING PROGRAM, A PT WAS ADMINISTERED 2MLS OF 10,000 UNIT/ML HEPARIN INSTEAD OF 10 UNIT/ML CONCENTRATION. THE PHARMACIST WAS UNAWARE THAT THE PHARMACY STOCKED BOTH 10,000 UNITS/ML AND 10 UNITS/ML HEPARIN VIALS, HENCE A DISPENSING ERROR OCCURRED. BOTH OF THESE PRODUCTS ARE MFG BY DIFFERENT MFRS. BOTH PRODUCTS ARE SUPPLIED IN 1ML CLEAR GLASS VIALS WITH A BROWN CAP AND SIMILAR LABELS (ESI IS A WHITE LABEL WITH BLACK PRINT AND AN ORANGE ESI LOGO): HEPARIN 10,000 UNITS/ML IS MFG BY AMERICAN PHARMACEUTICAL PARTNERS, INC AND THE HEP-LOCK U/P IS MFG BY ESI. HEP-LOCK U/P HAS BEEN MADE IN THIS PRESENTATION SINCE 1983. EVENT THAT WAS DISCOVERED BY THE ADMINISTRATING RN IN REACTION TO LAB RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEP-LOCK PRESERVATIVE FREE HEPARIN LOCK FLUSH SOLUTION USP FMF WYETH-AYERST LABORATORIES NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 13 MO