BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME HSI 23CM PRECISION SPORT PACK

    MDR report key: 4220527 · Received November 3, 2014

    Report

    Report Number
    3009211636-2014-00137
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 18, 2014
    Report Date
    October 27, 2014
    Manufacturer
    COSTA RICA
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(6) 2015. THE CUSTOMER STATES THE PHYSICIAN PLACED A 23CM PALINDROME HSI PER IFU IN THE LEFT INTERNAL JUGULAR ON FRIDAY (B)(6) 2014. ON (B)(6) 2014, DURING DIALYSIS, A PINHOLE APPEARED IN THE SILICON EXTENSION OF THE CATHETER ABOVE THE BIFURCATION CAUSING LEAKAGE OF BLOOD. DIALYSIS WAS IMMEDIATELY STOPPED AND WILL HAVE TO HAVE THE CATHETER EXCHANGED THIS WEEK. PRIOR TO INSERTION, DR. (B)(6) CLAMPED THE END OF THE CATHETER AND ATTEMPTED TO PUSH SALINE THROUGH THE CATHETER IN ORDER TO CHECK FOR ANY WEAKNESS IN THE EXTENSIONS AND FOUND NONE. 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.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 11/03/2014. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWADED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(3) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THE PHYSICIAN PLACED A 23CM PALINDROME HSI PER IFU IN LEFT INTERNAL JUGULAR ON FRIDAY (B)(6) 2014. ON (B)(6) 2014, DURING DIALYSIS, A PINHOLE APPEARED IN THE SILICON EXTENSION OF THE CATHETER ABOVE THE BIFURCATION CAUSING LEAKAGE OF BLOOD. THE PATIENT IMMEDIATELY STOPPED DIALYSIS AND WILL HAVE TO HAVE THE CATHETER EXCHANGED THIS WEEK. PRIOR TO INSERTION, DR. (B)(6) CLAMPED THE END OF THE CATHETER AND ATTEMPTED TO PUSH SALINE THROUGH THE CATHETER IN ORDER TO CHECK FOR ANY WEAKNESS IN THE EXTENSIONS AND FOUND NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702951 PALINDROME HSI 23CM PRECISION SPORT PACK DIALYSIS CATHETER MSD COSTA RICA 8888123408P UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1