BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDCHEM PRODUCTS

    MDR report key: 21396 · Received February 9, 1995

    Report

    Report Number
    21396
    Event Type
    Injury
    Date Received
    February 9, 1995
    Date of Event
    October 14, 1994
    Report Date
    January 31, 1995
    Manufacturer
    MEDCHEM PRODUCTS, INC.
    Product Code
    FGH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON OCTOBER 11, 1994, A 78 YEAR OLD FEMALE PATIENT, HAD A 5G DOUBLE LUMEN PICC LINE PLACED IN THE RADIOLOGY DEPARTMENT. ON 10/14 WHILE TURNING THE PATIENT, THE PICC LINE CONNECTOR PIECE BROKE OFF OF THE IMPLANTED CATHETER. THE PATIENT WAS TAKEN TO SPECIAL PROCEDURES FOR REPLACEMENT OF ANOTHER LINE DUE TO DIFFICULTY WITH SUITABLE ACCESS SITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDCHEM PRODUCTS Implant GESCO PER-Q-CATH FGH MEDCHEM PRODUCTS, INC. UNKNOWN 030696

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention PICC LINE REPLACEMENT 10/14/94| ENDOTRACHAEL TUBE W/VENTILATOR| PICC LINE REPLACEMENT 10/21/94| PLASMAPHARESIS, DIALYSIS CATHETER W/HEMODIALYSIS,