BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT 11.5FX19.5 CE MAHURKAR

    MDR report key: 4223357 · Received November 4, 2014

    Report

    Report Number
    3009211636-2014-00142
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    September 10, 2014
    Report Date
    October 31, 2014
    Manufacturer
    COSTA RICA
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATES THAT A DRESSING WAS APPLIED TO THE PATIENT. AN HOUR AFTER, BLOOD STAINS WERE NOTICED ON THE DRESSING OF THE CATHETER. DURING REMOVAL THE CATHETER WAS BLEEDING. THE CATHETER TUBE WAS ACTUALLY CUT AT THE LEVEL OF THE SWAN NECK. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO CONSEQUENCES FOR THE PATIENT. IT WAS REPORTED THAT THE CUSTOMER DISCARDED THE CATHETER, SO THE SAMPLE WAS NOT RETURNED AND COULD NOT BE FURTHER EVALUATED. SAMPLE AND LOT NUMBER INFORMATION WAS NOT PROVIDED, DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED. THE COMPLAINT WAS INVESTIGATED, BUT SINCE NO SAMPLE WAS RETURNED TO COVIDIEN THE DEFECT COULD NOT BE CONFIRMED AND THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED. COMPLAINT TRENDING INFORMATION IS BEING REVIEWED ON A MONTHLY BASIS BY COVIDIEN AND IF A TREND IS OBSERVED, ACTIONS ARE TAKEN AS NECESSARY. IT SHOULD BE NOTED THAT IN-PROCESS CONTROLS (SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL, 100% IN PROCESS VISUAL INSPECTION AND VISUAL ACCEPTANCE SAMPLING) ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. THIS INFORMATION WILL BE UTILIZED FOR TRACKING AND TRENDING PURPOSES TO DETERMINE THE NEED FOR CORRECTIVE ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT THE DRESSING WAS APPLIED TO THE PATIENT. AN HOUR AFTER, BLOOD STAINS WERE NOTICED ON THE DRESSING OF THE CATHETER. DURING REMOVAL, THE CATHETER WAS BLEEDING. THE CATHETER TUBE WAS ACTUALLY CUT AT THE LEVEL OF THE SWAN NECK. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706576 KIT 11.5FX19.5 CE MAHURKAR DIALYSIS CATHETER MSD COSTA RICA 8813793013 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1