BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME 55/72 KIT W/ SLOT

    MDR report key: 4140708 · Received October 3, 2014

    Report

    Report Number
    3009211636-2014-00109
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 26, 2014
    Report Date
    October 1, 2014
    Manufacturer
    COSTA RICA
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 10/03/2014.AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    CUSTOMER STATES THAT DURING DIALYSIS TREATMENT IT WAS NOTICED THAT THE CATHETER HAD A PINHOLE LEAK IN THE AREA WHERE THE TUBES ARE CLAMPED. THE CATHETER WAS REPLACED WITH ANOTHER 55CM PALINDROME CATHETER. THERE WAS NO INJURY TO THE PATIENT. IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER DISCARDED THE CATHETER, SO THE SAMPLE WAS NOT RETURNED AND COULD NOT BE FURTHER EVALUATED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE LOT NUMBER IDENTIFIED BY THE CUSTOMER, 329744X. 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. 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 DURING DIALYSIS TREATMENT, A PINHOLE LEAK IN VENOUS SIDE WHERE YOU CLAMP THE TUBES WAS DISCOVERED. DR. (B)(6) EXCHANGED THE DEFECTIVE 55CM PALINDROME CATHETER WITH ANOTHER 55CM PALINDROME ON (B)(6) 2014. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619920 PALINDROME 55/72 KIT W/ SLOT DIALYSIS CATHETER MPB COSTA RICA 8888145018 329744X

    Patients

    Seq Age Sex Outcome Treatment
    1