BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAIN, FLAT, 10X4MM, PERFORATED

    MDR report key: 164057 · Received April 23, 1998

    Report

    Report Number
    1423507-1998-00125
    Event Type
    Malfunction
    Date Received
    April 23, 1998
    Date of Event
    January 5, 1998
    Report Date
    January 13, 1998
    Manufacturer
    ALLEGIANCE HEALTHCARE
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS REC'D INSIDE A POLY/TYVEK POUCH. THE CORRECT CATALOG NUMBER FOR THE RETURNED SAMPLE SHOULD BE SU130-1309. VISUAL INSPECTION REVEALED DRAIN FRACTURE AT MOLDED LPS FLAT DRAIN SECTION, BUT NOT AT PERFORATIONS AREA, AT APPROXIMATELY ONE INCH FROM DRAIN/TUBING JUNCTION AREA. MICROSCOPIC EXAMINATION REVEALED WAVY/JAGGED EDGES AT THE FRACTURED SITE. THE MINIMUM PULL TEST SPECIFICATION FOR THIS DRAIN IS 8.0 LBS. THE CHARACTERISTICS OF THE FRACTURED AREA ARE SIMILAR TO THOSE WHICH MAY HAVE BEEN CAUSED BY NICKS OR PUNCTURES BY A SHARP INSTRUMENT. THE PRODUCT INFO DATA SHEET WHICH PROVIDES DETAILED INFO REGARDING PRECAUTIONS FOR USING THESE DRAINS IS CONTAINED UNDER THE SECTION TITLED WARNINGS/COMPLICATIONS FOR CLOSED WOUND DRAINAGE SYSTEM. SPECIFICALLY CO WARNS AGAINST ANY FORM OF HANDLING THAT MAY RESULT IN BREAKAGE OF THE DRAINS; FOR EXAMPLE, NICKS, CUTS AND TEARS CAUSED BY PUNCTURES, SUTURES OR SHARP INSTRUMENTS. THIS INCLUDES HANDLING GENTLY AND WITHOUT EXCESSIVE FORCE. LASTLY, LEAVING THE DRAIN IMPLANTED FOR ANY PERIOD OF TIME WHICH ALLOWS FOR TISSUE INGROWTH AROUND THE DRAIN AND INTO THE HOLES MAY CAUSE BREAKAGE UPON REMOVAL.

    Description of Event or Problem · 1

    JACKSON PRATT WOUND DRAIN FRACTURED DURING REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAIN, FLAT, 10X4MM, PERFORATED Implant WOUND DRAIN GCY ALLEGIANCE HEALTHCARE SU130-1311 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other