BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NV LARGE BORE Y-IRRIGATION SET

    MDR report key: 571155 · Received January 25, 2005

    Report

    Report Number
    9615050-2005-00014
    Event Type
    Malfunction
    Date Received
    January 25, 2005
    Date of Event
    January 4, 2005
    Report Date
    January 4, 2005
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    EYN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING A TRANSURETHRAL RESECTION OF THE PROSTATE. THE CUSTOMER REPORTED THAT 3L GLYCINE BAGS WERE BEING CONSECUTIVELY SPIKED AND REPLACED BY THE CIRCULATING NURSE WHILE GLYCINE WAS DELIVERED VIA GRAVITY. THEIR ROUTINE IS TO CHANGE BAGS, OPEN THE FLOW WIDE OPEN, CLAMP OFF THE EMPTY LINE, AND SPIKE THE NEXT BAG. AFTER CHANGING BAG NUMBER 0 OR 10, THE SURGEON VISUALIZED A FOREIGN FRAGMENT, AND WAS ABLE TO REMOVE IT FROM THE BLADDER WITHOUT SIGNIFICANT DELAY. SUBSEQUENTLY, THE FRAGMENT WAS MATCHED UP WITH A BROKEN SECTION IN THE PIERCING PIN TIP AREA. THERE WAS NO ADVERSE PATIENT EFFECT.

    Description of Event or Problem · 2

    PATIENT WAS UNDERGOING A TRANSURETHRAL RESECTION OF THE PROSTATE. THE CUSTOMER REPORTED THAT 3L GLYCINE BAGS WERE BEING CONSECUTIVELY SPIKED AND REPLACED BY THE CIRCULATING NURSE WHILE GLYCINE WAS DELIVERED VIA GRAVITY. THEIR ROUTINE IS TO CHANGE BAGS, OPEN THE FLOW WIDE OPEN, CLAMP OFF THE EMPTY LINE, AND SPIKE THE NEXT BAG. AFTER CHANGING BAG NUMBER 9 OR 10, THE SURGEON VISUALIZED A FOREIGN FRAGMENT, AND WAS ABLE TO REMOVE IT FROM THE BLADDER WITHOUT SIGNIFICANT DELAY. SUBSEQUENTLY, THE FRAGMENT WAS MATCHED UP WITH A BROKEN SECTION IN THE PIERCING PIN TIP AREA. THERE WAS NO ADVERSE PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NV LARGE BORE Y-IRRIGATION SET IRRIGATION SET EYN HOSPIRA DE COSTA RICA LTD. NA 201295H

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other ABBOTT LABORATORIES, INC.| GLYCINE IRRIGATION SOLUTION, MANUFACTURED BY
    2 67 YR GLYCINE IRRIGATION SOLUTION, MFD BY ABBOTT LAB INC