BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPROCESSED DECANAV EP CATHETER, F CURVE

    MDR report key: 25118340 · Received May 7, 2026

    Report

    Report Number
    2134070-2026-00010
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 15, 2026
    Manufacturer
    STERILMED, INC.
    Product Code
    NLH
    UDI-DI
    10888551045704
    PMA / PMN Number
    K240826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY STERILMED INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, STERILMED INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SHIPMENT OF REPROCESSED DECANAV EP CATHETER, F CURVE, WAS RECEIVED AND THE BOXES WERE DAMAGED (SMASHED). THE CATHETERS INSIDE WERE COMPROMISED, THE INSIDE PACKAGING WAS ALSO DAMAGED. THERE WAS NO PROCEDURE INVOLVED. BASED ON THE SEVERITY OF THE DAMAGE, IT IS POSSIBLE THE STERILITY WAS COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480307 REPROCESSED DECANAV EP CATHETER, F CURVE CATHETER, RECORDING, ELECTRODE, REPROCESSED NLH STERILMED, INC. 2253778 10888551045704

    Patients

    Seq Age Sex Outcome Treatment
    1