BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL INSUFFLATION TUBING WITH FILTER

    MDR report key: 1932153 · Received December 1, 2010

    Report

    Report Number
    3004605321-2010-00002
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    July 2, 2010
    Report Date
    July 2, 2010
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    NKC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S DEVICE INVESTIGATION REVEALED THE PLASTICIZER IN THE TUBING MIGRATED AND SOFTENED THE FILTER HOUSING MATERIAL CAUSING AN OCCLUSION. HEAT WAS FOUND TO AGGRAVATE THE ACTION. THE FILTER HOUSING MATERIAL WAS SUBSEQUENTLY CHANGED TO POLYCARBONATE WHICH IS A STRONGER, HIGHER IMPACT AND MORE CHEMICALLY RESISTANT MATERIAL ALSO LESS AFFECTED BY HIGHER TEMPERATURES. THIS ACTION HAS ELIMINATED THE OCCLUSION ISSUES AS REPORTED BY THE FACILITY. THE CUSTOMER HAS ALSO ADVISED THERE WAS NO INJURY OR ILLNESS DUE TO THE DEVICE MALFUNCTION, HOWEVER; IT DID PROLONG SURGERY TIME.

    Description of Event or Problem · 1

    LAPAROSCOPIC INSUFFLATION TUBING WITH APPARENT RESTRICTED FLOW DURING SURGERY RESULTED IN LIMITED PNEUMOPERITONEUM AND EXTENDED ANESTHESIA TIME FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEROYAL INSUFFLATION TUBING WITH FILTER INSUFFLATION TUBING AND FILTER NKC DEROYAL INDUSTRIES, INC. 21775446

    Patients

    Seq Age Sex Outcome Treatment
    1 Other