BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAHURKAR DUAL LUMEN CATHETER

    MDR report key: 98594 · Received June 12, 1997

    Report

    Report Number
    3014398-1997-00026
    Event Type
    Malfunction
    Date Received
    June 12, 1997
    Date of Event
    April 28, 1997
    Product Code
    LFJ
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE ACTUAL CATHETER WAS PERFORMED ON-SITE AT THE USER FACILITY. AN IN-HOUSE ENGINEER'S REVIEW OF THE EXAMINATION DETERMINED THAT THE CATHETER'S SILICONE EXTENSION TUBE MAY HAVE HAD A SHALLOW NICK OR CUT ON THE SURFACE OF THE TUBING, CREATING A TEAR PROPAGATION POINT. THE JAGGED APPEARANCE OF THE BREAK IS CHARACTERISTIC OF A TEAR FAILURE. HOWEVER, THE LACK OF TUBING ELONGATION POINTS TO THE EXISTANCE OF A TEAR PROPAGATION POINT AS A RESULT OF SURFACE DAMAGE. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY QUINTON INSTRUMENT CO TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY QUINTON INSTRUMENT CO THAT ONE OF ITS PRODUCTS HAS CAUSED OF CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAHURKAR DUAL LUMEN CATHETER HEMODIALYSIS CATHETER LFJ NA 800356-1996-10

    Patients

    Seq Age Sex Outcome Treatment
    1 *