BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALINDROME

    MDR report key: 16882167 · Received May 5, 2023

    Report

    Report Number
    3009211636-2023-00136
    Event Type
    Injury
    Date Received
    May 5, 2023
    Date of Event
    March 7, 2023
    Report Date
    May 5, 2023
    Manufacturer
    COVIDIEN MFG SOLUTIONS S.A.
    Product Code
    NYU
    UDI-DI
    10884521158085
    PMA / PMN Number
    K123196
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: 8888145044CP, 8888145044CP 23CM P H KIT VT CE (LOT#2014900162). MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, PATIENT WAS ADMITTED WITH STAPHYLOCOCCUS AUREUS BACTERAEMIA (SAB) UNDERGOING TREATMENT WHEN IT WAS NOTICED THERE WAS A PROBABLE HOLE IN DIALYSIS CATHETER, THIS WAS DETECTED AS AIR IN DIALYSIS MACHINE. USE WAS DISCONTINUED, PATIENT INFORMED THE ISSUE, AND TCVC (TUNNELED CENTRAL VENOUS CATHETER) WAS REMOVED THAT SAME DAY FOR SAFETY. PATIENT HAD REOCCURRING SAB SINCE AND PATIENT TREATED WITH ANTIBIOTICS. PATIENT WAS NOW BEING TREATED FOR ENDOCARDITIS AND WOULD NEED HEART VALVE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2213120 PALINDROME CATHETER, HEMODIALYSIS, IMPLANTED, COATED NYU COVIDIEN MFG SOLUTIONS S.A. 8888145044CP 2014900162 10884521158085

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Unknown Required Intervention PLEASE SEE NOTE ON H10