BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-CATH® II TSUI

    MDR report key: 20879198 · Received December 9, 2024

    Report

    Report Number
    9611612-2024-00032
    Event Type
    Malfunction
    Date Received
    December 9, 2024
    Date of Event
    November 26, 2024
    Report Date
    December 18, 2024
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    PMA / PMN Number
    K152925
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IRN#: (B)(4). COMPLAINT TOOK PLACE IN USA. THE A, B, C, D, E AND G CODES HAVE BEEN CHANGED/ADJUSTED IN THIS FU1 REPORT COMPARED TO THE INTIAL REPORT. THESE HAVE RESULTED FROM THE SUBMITTED FAILURE PATTERN. BASED ON CLINICAL ASSESSMENT AND RISK ASSESSMENT THIS CASE IS CONSIDERED AS CLOSED. IN CASE NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY.

    Additional Manufacturer Narrative · 0

    IRN# (B)(4) COMPLAINT TOOK PLACE IN USA. ALL CODES MUST BE FILLED IN FOR THE INITIAL REPORT, ALTHOUGH THE INITIAL REPORT DID NOT PREVIOUSLY REQUIRE THE B, C AND D CODES. OTHERWISE, THE PACKING OF THE PARCELS WILL NOT WORK. IN THE SUBSEQUENT FU1 WITH THE DETERMINED TEST RESULTS, THESE CAN CHANGE AGAIN! AT THE TIME OF THE COMPLAINT, THE AFFECTED FAILURE PATTERN HAS NOT YET BEEN SENT IN FOR EXAMINATION. THE CURRENT PROCESSING STATUS DOES NOT YET INCLUDE THE COMPLETE ANALYSIS AND TEST RESULTS, WHICH WILL BE TRANSMITTED WITH THE SUBSEQUENT FU2.

    Description of Event or Problem · 0

    IRN#: (B)(4). INCIDENT OCCURRED IN USA: THE NURSE WAS UNABLE TO GET THE NEEDLE TO FLUSH. WAS TOLD THAT THEY TAKE THE STIMULATION CORD OFF BEFORE DOING THE BLOCK. THEY NOTICE THAT WHEN THEY INJECT THE LIQUID COMES OUT THE TOP OF THE CATHETER WHERE THEY PULLED THE STIMULATION CORD OUT.

    Description of Event or Problem · 0

    IRN# (B)(4) INCIDENT OCCURRED IN USA: THE NURSE WAS UNABLE TO GET THE NEEDLE TO FLUSH. WAS TOLD THAT THEY TAKE THE STIMULATION CORD OFF BEFORE DOING THE BLOCK. THEY NOTICE THAT WHEN THEY INJECT THE LIQUID COMES OUT THE TOP OF THE CATHETER WHERE THEY PULLED THE STIMULATION CORD OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337613 E-CATH® II TSUI E-CATH® II TSUI_ANESTHESIA CONDUCTION KIT CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE BH060044 1527

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other