BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    PALINDROME PRECISION HSI CHRONIC CATHETER

    MDR report key: 15417129 · Received September 14, 2022

    Report

    Report Number
    15417129
    Event Type
    No answer provided
    Date Received
    September 14, 2022
    Date of Event
    June 10, 2022
    Report Date
    September 5, 2022
    Manufacturer
    COVIDIEN LP
    Product Code
    MSD
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTING FOR PATIENT POTENTIALLY AFFECTED BY URGENT MEDICAL DEVICE RECALL NOTICE RECEIVED ON (B)(6) 2022 VIA UPS GROUND. UPON REVIEWING AFFECTED INVENTORY, A PATIENT WAS IDENTIFIED AS HAVING A PERMACATH PLACED. 2 UNUSED DEVICES REMOVED FROM INVENTORY AND MATERIAL MANAGER MADE AWARE. CURRENTLY AWAITING RGA RETURN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2673049 PALINDROME PRECISION HSI CHRONIC CATHETER CATHETER, HEMODIALYSIS, IMPLANTED MSD COVIDIEN LP 8888123409P 2127200429

    Patients

    Seq Age Sex Outcome Treatment
    1 24820 DA Female