BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENOXAPARIN CARPUJECT

    MDR report key: 10683095 · Received October 15, 2020

    Report

    Report Number
    10683095
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    May 9, 2020
    Report Date
    September 9, 2020
    Manufacturer
    FRESENIUS KABI WARRENDALE
    Product Code
    IQG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE RN REMOVED THE ENOXAPARIN CARPUJECT FROM THE PYXIS AND SHE NOTED THE CARPUJECT CAME OFF/SEPARATED FROM THE GLASS SYRINGE. THE EQUIPMENT WAS NOT USABLE AND UNABLE TO ADMINISTER THAT DOSE OF MEDICATION. THIS DID NOT REACH THE PATIENT. PHARMACY NOTIFIED AND REPLACED MEDICATION DEVICE. PHARMACY NOTES CONTINUE TO MONITOR FOR SIMILAR ISSUES. NO FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146842 ENOXAPARIN CARPUJECT ADAPTOR, HOLDER, SYRINGE IQG FRESENIUS KABI WARRENDALE 682158

    Patients

    Seq Age Sex Outcome Treatment
    1