BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-CATH® II TSUI

    MDR report key: 20889723 · Received December 10, 2024

    Report

    Report Number
    9611612-2024-00031
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    November 27, 2024
    Report Date
    December 18, 2024
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    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. THE B, C, D AND G CODES HAVE BEEN CHANGED/ADJUSTED IN THIS FU1 REPORT COMPARED TO THE INTIAL 12/10/2024 REPORT. 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 FU1.

    Description of Event or Problem · 0

    IRN#: (B)(4). INCIDENT OCCURRED IN USA: PULLED OUT THE STIMULATION CORD. WENT TO ASPIRATE AND IT SUCKED AIR INTO THE SYRINGE. TRIED TO PUSH MEDS AND IT LEAKED OUT THE TOP. WAS NOT ABLE TO COMPLETE THE PROCEDURE USING THIS CATHETER. HAD TO USE A NEW CATHETER AND DIDN'T PULL THE STIMULATION CORD OUT AND HAD NO PROBLEMS.

    Description of Event or Problem · 0

    IRN# (B)(4). INCIDENT OCCURRED IN USA: PULLED OUT THE STIMULATION CORD. WENT TO ASPIRATE AND IT SUCKED AIR INTO THE SYRINGE. TRIED TO PUSH MEDS AND IT LEAKED OUT THE TOP. WAS NOT ABLE TO COMPLETE THE PROCEDURE USING THIS CATHETER. HAD TO USE A NEW CATHETER AND DIDN'T PULL THE STIMULATION CORD OUT AND HAD NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2523482 E-CATH® II TSUI E-CATH® II TSUI_ANESTHESIA CONDUCTION KIT CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE 311285-40E 1516

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other