BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITA JET LIGHT II HP PUR KIT WITH 6.6F X 750 MM PRE-ATTACHED POLYURETHANE CATHET

    MDR report key: 21494755 · Received February 28, 2025

    Report

    Report Number
    3008737795-2025-00004
    Event Type
    Injury
    Date Received
    February 28, 2025
    Date of Event
    July 1, 2025
    Report Date
    February 28, 2025
    Manufacturer
    PFM MEDICAL MEPRO GMBH
    Product Code
    LJT
    PMA / PMN Number
    K072481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT FOR ADVERSE EVENT. THE MANUFACTURER CONDUCTED A DOCUMENTARY AND RETURNED PRODUCT INVESTIGATION INTO THE REPORTED PROBLEM WITH COMPLETE, DHR AND TESTING DATA REVIEW AND PRODUCT REVIEW: THIS DOCUMENT REVIEW CONCLUDED THAT THE PRODUCT (PROCEDURE PACK) MEETS ITS SPECIFICATION. THE PRODUCT REVIEW PERFORMED BY PFM CPP COULD NOT REPRODUCE THE REPORTED LEAK NOR DRAW A FORMALCONCLUSION. BASE UPON THE INVESTIGATION RESULT, THIS COMPLAINT IS CLASSIFIED: UNJUSTIFIED, USE ERROR. ITEM NUMBER, ITEM DESCRIPTION, LOT NUMBER, EXPIRATION DATE, MANUFACTURING DATE, UDI: (B)(4), TJL II CONTRAST BASIC PUR 1.3 X 2.2MM, 155179, 02/21/2027, 04/29/2024, UNKNOWN.

    Description of Event or Problem · 0

    PORT INSERTED ON (B)(6)2025. SUSPICION OF EXTRAVASATION FOLLOWING FIRST CHEMOTHERAPY TREATMENT. CLINICAL TEAM WHO PLACED HUBER NEEDLE (BBRAUN SURECAN SAFETY 2) STATE THAT CORRECT PLACEMENT HAD BEEN VERIFIED WITH BLOOD ASPIRATION AND HAD NO PROBLEMS WITH FLUSHING. SUBSEQUENT EXTENSIVE TISSUE DAMAGE REQUIRING PLASTIC SURGICAL INTERVENTION. NEED TO RULE OUT ANY PROBLEMS WITH THE PORT WHICH MAY HAVE CAUSED THE EXTRAVASATION INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122178 TITA JET LIGHT II HP PUR KIT WITH 6.6F X 750 MM PRE-ATTACHED POLYURETHANE CATHET PROCEDURE TRAY KIT LJT PFM MEDICAL MEPRO GMBH 61.636.83.077-V 155179000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention