BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAVE INJECTION SITE

    MDR report key: 60136 · Received January 3, 1997

    Report

    Report Number
    MW1010514
    Event Type
    Malfunction
    Date Received
    January 3, 1997
    Date of Event
    December 10, 1996
    Report Date
    December 20, 1996
    Manufacturer
    MC GAW, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PERIPHERAL IV INSERTED WITH 6" EXTENSION SET AND INJECTION CAP APPLIED. UNABLE TO OBTAIN BLOOD RETURN FROM INJECTION CAP. INJECTION CAP REMOVED. DIRECT CONNECT TO EXTENSION SET, BLOOD RETURN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAVE INJECTION SITE INJECTION SITE FOZ MC GAW, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR 12/10/96 - ONE TIME DOSE OF ANCEF AND GENTAMICIN