BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER/EXACT CODE NOT KNOWN

    MDR report key: 36806 · Received August 30, 1996

    Report

    Report Number
    1618732-1996-00004
    Event Type
    Injury
    Date Received
    August 30, 1996
    Date of Event
    August 8, 1996
    Report Date
    August 26, 1996
    Manufacturer
    JOHNSON & JOHNSON MEDICAL, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 10/11/96. H2 - JOHNSON & JOHNSON MEDICAL, INC. HAS DECIDED TO DISCONTINUE MFR AND SALE OF THE STREAMLINE, LANDMARK AND CENTERMARK BRANDS OF I.V. CATHETERS AS OF 9/18/96.

    Description of Event or Problem · 1

    AFTER INSERTION AND FLUSHING OF THE DEVICE WITH A PRESERVED SALINE SOLUTION THE PT STATED, "I FEEL FUNNY". THE PT COMPLAINED OF A BURNING SENSATION IN THE MOUTH, FACE WAS FLUSH, AND SHE FELT WOOZY AND LIGHTHEADED. THE PT WAS LAYING SUPINE AND WAS NOT EXPRESSING ANXIETY. THE CATHETER WAS IMMEDIATELY REMOVED AND THE PT SYMPTOMS WERE RESOLVING WHEN THE DR ORDERED HISMANAL 10MG AND ZANTAC 150MG TIMES ONE DOSE. THE PT DID NOT REQUIRE ANY ADD'L RESTICKS AND TREATMENT WAS COMPLETED WITH A PERIPHERAL LINE THAT WAS ALREADY IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER/EXACT CODE NOT KNOWN Implant PERIPHERALLY INSERTED CENTRAL CATHETER DQO JOHNSON & JOHNSON MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention