BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK INJECTION SITE

    MDR report key: 53288 · Received November 20, 1996

    Report

    Report Number
    6000001-1996-00244
    Event Type
    Malfunction
    Date Received
    November 20, 1996
    Date of Event
    August 6, 1996
    Report Date
    October 21, 1996
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    1 YR OLD FEMALE PREVIOUSLR A PT AT A HOSP AND FOLLOWED BY A HOME HEALTH CARE AGENCY WHERE INJECTION SITES REPORTEDLY WERE USED IN CONJUNCTION WITH THE PT'S CATHETER. UPON ADMITTANCE TO FACILITY FOR DEHYDRATION AND GASTROENTERITIS, VALVE WAS APPLIED IN PLACE OF THE INJECTION SITE AND PER ACCOUNT, "IT APPEARS THE CO CATHETER STRETCHED THE CATHETER CAUSING THE LEAKEAGE TO OCCUR AT THE LOCK CAP WHEN THE VALVE WAS USED". THE PT "GREW OUT BACILIUS SPECIES FROM A CENTRAL VENOUS CATHETER. PT PLACED ON A 7 DAY COURSE OF ANTIBIOTICS. PT READMITTED AND HAD THE CATHETER REMOVED DUE TO POSITIVE BLOOD CULTURES WHILE ON ANTIBIOTICS. PT HAD ANOTHER CENTRAL VENOUS CATHETER PLACED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK INJECTION SITE INJECTION SITE FOZ BAXTER HEALTHCARE PTE. LTD. NA NA02

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO COOK TPN DOUBLE LUMEN 7 FR CENTRAL VENCOUS| CATHETER