BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EP DIAGNOSTIC CATHETER QUADRIPOLAR D-TYPE/BLUE

    MDR report key: 10532164 · Received September 14, 2020

    Report

    Report Number
    2134070-2020-00007
    Event Type
    Malfunction
    Date Received
    September 14, 2020
    Date of Event
    August 20, 2020
    Report Date
    August 20, 2020
    Manufacturer
    STERILMED, INC.
    Product Code
    NLH
    UDI-DI
    10888551006408
    PMA / PMN Number
    K043513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH AN EP DIAGNOSTIC CATHETER QUADRIPOLAR D-TYPE/BLUE AND THE BLUE COATING ON THE TIP OF CATHETER WAS SHEARED OFF. THE RETURNED PRODUCT WAS VISUALLY EXAMINED UNDER A MAGNIFICATION SCOPE. WHILE THERE WERE OBSERVED CONTAMINANTS ON THE HANDLE AND SHAFT OF THE DEVICE, UPON RECEIPT, THE DEVICE APPEARS FREE FROM STAINS OR DISCOLORATION. THERE ARE NO OBSERVED CUTS, GOUGES, SCRAPES, DENTS, DEFECTS, PHYSICAL ABNORMALITIES AND OTHER DAMAGE. THE DEVICE'S SHAFT DOES NOT APPEAR KINKED OR DEFORMED DUE TO TWISTING OR BENDING. AND ALL JOINTS AND ELECTRODES APPEAR INTACT WITH NO VISUAL SEPARATION OR DAMAGE. THE DEVICE APPEARS WHOLE AND INTACT. THERE IS NO INDICATION OF ANY PART OF THE DEVICE OR TIP BEING SHEARED OFF. THE REPORTED ISSUE IS NOT CONFIRMED. THE DEVICE HISTORY RECORD FOR LOT 2133664 SHOWS THAT THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL CRITERIA PRIOR TO BEING DISTRIBUTED TO THE CUSTOMER. A MANUFACTURING RECORD EVALUATION WAS CONDUCTED AND THERE WERE NO IDENTIFIED NONCONFORMANCES. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH AN EP DIAGNOSTIC CATHETER QUADRIPOLAR D-TYPE/BLUE AND THE BLUE COATING ON THE TIP OF CATHETER WAS SHEARED OFF. THERE WAS NO PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992526 EP DIAGNOSTIC CATHETER QUADRIPOLAR D-TYPE/BLUE CATHETER, RECORDING, ELECTRODE, REPROCESSED NLH STERILMED, INC. BIOD6-DR-005-RT 2133664 10888551006408

    Patients

    Seq Age Sex Outcome Treatment
    1