BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPROCESSED NRG TRANSSEPTAL NEEDLE, 71 CM

    MDR report key: 16700593 · Received April 7, 2023

    Report

    Report Number
    16700593
    Event Type
    Malfunction
    Date Received
    April 7, 2023
    Date of Event
    February 22, 2023
    Report Date
    March 28, 2023
    Manufacturer
    INNOVATIVE HEALTH LLC
    Product Code
    QLZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ELDERLY MALE PATIENT, WHILE UNDERGOING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE BAYLIS REPROCESSED TRANS-SEPTAL NEEDLE WAS INSERTED INTO THE ST. JUDE¿S SL-0 SHEATH TO PERFORM THE TRANS-SEPTAL PUNCTURE UNDER ICE (INTRACARDIAC ECHOCARDIOGRAPHY) VIEWS. THE REPROCESSED BAYLIS NEEDLE WAS NOTED TO BE NOT REGISTERING WITH THE BAYLIS RF GENERATOR. THE "ALERT A015" CODE WAS NOTED-INVALID DEVICE DETECTED. RECORD ALERT CODE AND CONTACT BAYLIS CLINICAL SUPPORT." ANOTHER REPROCESSED BAYLIS NEEDLE WAS USED IN PLACE OF THE FIRST NEEDLE AND WORKED PROPERLY. THE PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT AND THERE WAS NO HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR NEELE, TRANS-SEPTAL NEEDLE (PER SITE REPORTER) THE MEDLINE CUSTOMER SUPPORT WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1754494 REPROCESSED NRG TRANSSEPTAL NEEDLE, 71 CM SEPTOSTOMY CATHETER, REPROCESSED QLZ INNOVATIVE HEALTH LLC 100096947

    Patients

    Seq Age Sex Outcome Treatment
    1 26645 DA Male