BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME SAPPHIRE 33/50KT VT

    MDR report key: 4121773 · Received July 28, 2014

    Report

    Report Number
    3009211636-2014-00029
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    COSTA RICA COVIDIEN MANUFACTURING
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE SEE SECTION FOR INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2014. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    THE PRODUCT SAMPLE WAS NOT RETURNED AND NO PHOTOS WERE RECEIVED. BOTH DHRS WERE REVIEWED AND NO DEVIATIONS RELATED TO THIS FAILURE MODE WERE FOUND. THERE ARE NOT NCRS RELATED TO THE REPORTED ISSUE. THIS DEFECT HAS NOT BEEN CONFIRMED. THE PRODUCT SAMPLE WAS NOT RETURNED TO THE MANUFACTURING SITE FOR REVIEW. WITH THE AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE COULD BE CONSIDERED AS MISUSE (KINKING COULD BE MORE LIKELY CAUSED DUE TO THE PATIENT'S POSITION). HOWEVER WITHOUT THE SAMPLE, THIS CANNOT BE CONFIRMED. NO ADDITIONAL ACTIONS ARE REQUIRED. IT MUST 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. PER PROCEDURE, MANUFACTURING PERFORMS 100% FINAL INSPECTION, WHICH WOULD IDENTIFY THIS ISSUE IN THE CATHETER ASSEMBLY. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT THE DOCTOR USED THE PALINDROME (LOT 213810X) FOR DIALYSIS TREATMENT, BUT THE PT HAD TO STAY IN AN UNCOMFORTABLE POSITION WHICH RESULTED IN MINIMUM FLOW. THE DOCTOR CHANGED THE CATHETER (LOT 320618X) AND STILL DID NOT WORK. IT SEEMED THAT THE CATHETER WAS KINKING. THE THIRD SURGERY WAS DONE AND A CATHETER WAS INSERTED SPLIT CATH AND WORKED SATISFACTORILY. THE CURRENT STATE OF THE PT IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439807 PALINDROME SAPPHIRE 33/50KT VT DIALYSIS CATHETER MSD COSTA RICA COVIDIEN MANUFACTURING 8888145050 320618X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK