BEUDAMED
    FDA Adverse Event Other Summary report: N

    L-CATH PERIPHERALLY INSERTED VENOUS CATH

    MDR report key: 113702 · Received August 15, 1997

    Report

    Report Number
    2022441-1997-00011
    Event Type
    Other
    Date Received
    August 15, 1997
    Date of Event
    May 8, 1997
    Report Date
    June 25, 1997
    Manufacturer
    LUTHER MEDICAL PRODUCTS
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FEMALE INFANT BORN 4/12/97, WEIGHING 810 GRAMS, 27 WEEKS GESTATION TRANSFERRED TO NEONATAL ICU. ON 4/26/97 A PICC CATHETER WAS INSERTED. ON 5/8/97 BABY WAS NOTED TO HAVE ACUTE CLINICAL DETERIORATION. BABY CODED, CPR INITIATED, RESUSCITATION EFFORTS WERE UNSUCCESSFUL. AUTOPSY PERFORMED ON 5/12/97. COPY OF AUTOPSY REPORT NOT INCLUDED IN DOCUMENTS REC'D AT LUTHER MEDICAL PRODUCTS, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-CATH PERIPHERALLY INSERTED VENOUS CATH PICC CATHETER DQO LUTHER MEDICAL PRODUCTS 28 GAUGE 1.2 FR 20CM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 DAY Death