BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUILL CATHETER GUIDE IN Y-TEC IMPLANTATION PAC

    MDR report key: 1975570 · Received January 25, 2011

    Report

    Report Number
    1450420-2011-00001
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 27, 2010
    Manufacturer
    MEDIGROUP, INC.
    Product Code
    FJS
    PMA / PMN Number
    K823303A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE SALES HISTORY OF THE FACILITY WHERE EVENT OCCURRED DURING THE POSSIBLE TIME FRAME WHEN THE PRODUCT WAS PURCHASED, THE PRODUCT COULD HAVE BEEN 1 OF 3 LOT NUMBERS. RECORDS OF ALL THOSE LOT NUMBERS WERE CHECKED, AND NO OTHER COMPLAINTS FOR THIS DEFECT HAVE BEEN RECEIVED. DUE TO THE PASSAGE OF TIME, NO OTHER PRODUCTS WITH THOSE LOT NUMBERS ARE AVAILABLE FOR EXAMINATION.

    Description of Event or Problem · 1

    PATIENT HAD A PERITONEAL DIALYSIS CATHETER PLACED IN APPROXIMATELY (B)(6) 2009 WITHOUT PROBLEM. THE CATHETER WAS REMOVED IN (B)(6) 2010. IN (B)(6) 2010, PATIENT DEVELOPED SPONTANEOUS APPENDICITIS AND HAD AN APPENDECTOMY. DURING THE OPERATION, THE PHYSICIAN NOTICED ADHESIONS OF BOTH BOWEL AND OMENTUM UP TO THE ANTERIOR ABDOMINAL WALL, AND IN THE UPPER RIGHT QUADRANT, THERE WAS A PALPABLE TUBULAR STRUCTURE NOTED, AND IT WAS REMOVED. IT WAS SUSPECTED TO BE A PIECE OF PLASTIC TUBING FROM THE INTRODUCER USED IN THE CATHETER PLACEMENT IN APPROXIMATELY (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL CATHETER GUIDE IN Y-TEC IMPLANTATION PAC PERITONEAL DIALYSIS CATHETER INTRODUCER FJS MEDIGROUP, INC. VP-210 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention