BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-KATHETER II SET TSUI

    MDR report key: 21401512 · Received February 18, 2025

    Report

    Report Number
    9611612-2025-00005
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    February 10, 2025
    Report Date
    March 5, 2025
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    BSO
    UDI-DI
    04048223121931
    PMA / PMN Number
    K152952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IRN#(B)(4) COMPLAINT TOOK PLACE IN USA. UNDER ITEM H6, CODES B, C AND D, PLACEHOLDERS HAVE BEEN INSERTED THAT HAVE NOT BEEN VERIFIED, AS THE INTIAL REPORT CAN ONLY BE PACKED IN THIS FORM IF THESE ARE FILLED IN, ALTHOUGH NO ANALYSIS HAS YET TAKEN PLACE. THESE B, C AND D CODES CAN ONLY BE TRANSMITTED CORRECTLY IN THE SUBSEQUENT MESSAGE AS THE ANALYSIS IS STILL BEING PROCESSED. YOU WILL RECEIVE THE COMPLETE REPORT WITH ALL TEST RESULTS IN THE SUBSEQUENT MESSAGE.

    Additional Manufacturer Narrative · 0

    IRN# (B)(4) COMPLAINT TOOK PLACE IN USA. PLACEHOLDERS WERE INSERTED UNDER POINT H6, CODES B, C AND D, WHICH WERE NOT VERIFIED, AS THE INITIAL REPORT COULD ONLY BE PACKAGED IN THIS FORM IF THEY WERE FILLED IN. IN THIS FINAL REPORT, THESE PLACEHOLDERS FROM THE FIRST REPORT WERE CHANGED AFTER THE ROOT CAUSE ANALYSIS. THIS CONCERNS CODES B, C AND D. BASED ON RISK ASSESSMENT AND CLINICAL ASSESSMENT THIS FILE IS CONSIDERED AS CLOSED. IN CASE NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY.

    Description of Event or Problem · 0

    IRN# (B)(4) INCIDENT OCCURRED IN USA: SAYS THEY COULD NOT BOLUS THROUGH THE CATHETER.

    Description of Event or Problem · 0

    IRN# (B)(4) INCIDENT OCCURRED IN USA: SAYS THEY COULD NOT BOLUS THROUGH THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2669475 E-KATHETER II SET TSUI E-KATHETER II SET TSUI_CATHETER, CONDUCTION, ANESTHETIC BSO PAJUNK GMBH MEDIZINTECHNOLOGIE AA610027 1528 04048223121931

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other