BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSERTION TRAY

    MDR report key: 271876 · Received March 31, 2000

    Report

    Report Number
    1056436-2000-00057
    Event Type
    Other
    Date Received
    March 31, 2000
    Date of Event
    March 2, 2000
    Report Date
    March 3, 2000
    Manufacturer
    NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    KOC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 03/03/2000, THE FACILITY'S MATERIALS MANAGER/SAFETY OFFICER INFORMED THE MANUFACTURER'S (MFR.) REP OF THE FOLLOWING: THE PHYSICIAN WAS IMPLANTING THE DEVICE AND DURING IRRIGATION, DISCOVERED A "PINHOLE" AND LEAK ON THE VENOUS EXTENSION LEG. TWO (2) MORE DEVICES WERE OPENED AND THE SAME PROBLEM WAS ENCOUNTERED. A FOURTH DEVICE WAS OPENED AND REVEALED NO LEAKS. THE PHYSICIAN WAS ANGRY AND PLACED ALL THE DEVICES IN THE TRASH. O.R. WAS ABLE TO SALVAGE ONE DEVICE (LOT# UNK) FOR RETURN TO THE MFR FOR ANALYSIS. PER THE REPORT, THE PHYSICIAN STATED THAT THEY USED THREE (3) EACH ON 03/02/2000, AND ALL THREE (3) HAD "PINHOLES" ON THE VENOUS SIDE OF THE CATHETER (LOT#'S UNK). THE FACILITY OPENED ONE (1) EACH OF LOT# SE99427 FOR TESTING AND NO LEAKS WERE OBSERVED. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSERTION TRAY ACUTE POLYURETHANE CATHETER KOC NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other