BEUDAMED
    FDA Adverse Event Death Summary report: N

    10FR BIO-FLEX TESIO CATHETER

    MDR report key: 409840 · Received August 9, 2002

    Report

    Report Number
    409840
    Event Type
    Death
    Date Received
    August 9, 2002
    Date of Event
    June 25, 2002
    Report Date
    August 8, 2002
    Manufacturer
    PRODUCTS FOR SURGERY
    Product Code
    LFJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT EXPIRED 1 HOUR AFTER TESIO INSERTION. DEATH SUMMARY: SEPSIS, STAPH AUREUS. AUTOPSY PERFORMED: RESULTS RECEIVED 8/2002. DEATH DUE TO CARDIAC TAMPONADE DUE TO RIGHT VENTRICLE PERFORATION ASSOCIATED WITH CENTRAL LINE PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10FR BIO-FLEX TESIO CATHETER RIGHT SIDE APPROACH IV-CENTRAL CATH LFJ PRODUCTS FOR SURGERY B7R-6 M209470

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death ACCIDENT BACK PAIN.| STRIPPING RT BREAST 1BX. 06/12/2002 - POST WORK| MELANOMA 1976, 1982, HYSTERECTOMY 1964, VEIN