BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COILED PERITONEAL CATHETER

    MDR report key: 223583 · Received May 18, 1999

    Report

    Report Number
    1056436-1999-00095
    Event Type
    Injury
    Date Received
    May 18, 1999
    Report Date
    May 5, 1999
    Manufacturer
    NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    FJS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 05/05/1999, THE INTERNATIONAL DISTRIBUTOR INFORMED THE MFR VIA A FAXED REPORT OF THE FOLLOWING: THE CATHETER CUFFS ARE DISTORTED AND HAVE RIGID EDGES MAKING THE CUFFS ALMOST "TRIANGULAR" IN SHAPE, NOT ROUND. THIS CAUSES THE CATHETER TO LEAK, RESULTING IN PT PROBLEMS (TRAUMA)? AN UNUSED SAMPLE FROM THE SAME LOT WAS SCHEDULED TO BE RETURNED TO THE MFR FOR ANALYSIS. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COILED PERITONEAL CATHETER CHRONIC SILICONE CATHETER FJS NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC. NA SE98320

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention