BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICU MEDICAL, INC

    MDR report key: 1673457 · Received April 30, 2010

    Report

    Report Number
    MW5015789
    Event Type
    Injury
    Date Received
    April 30, 2010
    Date of Event
    March 2, 2010
    Report Date
    April 20, 2010
    Manufacturer
    ICU MEDICAL, INC
    Product Code
    LFJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DIFFICULTY REMOVING CAP FROM END OF CENTRAL VENOUS CATHETER FOR RENAL DIALYSIS. REMOVAL DID OCCUR WITHOUT HARM TO PATIENT. DATES OF USE: UNKNOWN. DIAGNOSIS OR REASON FOR USE: FOR USE WITH RENAL DIALYSIS CATHETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICU MEDICAL, INC TEGO CAP LFJ ICU MEDICAL, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention