BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICATH

    MDR report key: 23126154 · Received September 23, 2025

    Report

    Report Number
    2245270-2025-00087
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    July 28, 2025
    Report Date
    September 23, 2025
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K041468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE RECEIVED THE CATHETER CONNECTED TO A NEEDLE-FREE DEVICE (A NON-VYGON GERMANY GMBH PRODUCT) AS THE FAULTY SAMPLE. THE CATHETER TUBE WAS SHORTENED BETWEEN 13CM AND 14 CM MARKING AND SNAPPED BETWEEN THE 19 CM AND 20 CM MARKING. MICROSCOPIC EXAMINATION REVEALED A DIAGONAL BREAK. BOTH FRACTURE SURFACES APPEARED SMOOTH AND EVEN, WITH VISIBLE GROOVES INDICATING MECHANICAL DAMAGE CAUSED BY A SHARP INSTRUMENT, SUCH AS SCISSORS OR A SCALPEL. IN ADDITION, A MANUFACTURING FAULT CAN BE RULED OUT, AS EACH CATHETER UNDERGOES FLOW AND LEAK TESTING DURING PRODUCTION, AND THE CATHETER FUNCTIONED AS INTENDED FOR 24 HOURS, AS REPORTED BY THE CUSTOMER. A REVIEW OF THE BATCH HISTORY RECORDS; NO DEVIATIONS WERE FOUND. THE BATCH COMPLIED WITH ITS SPECIFICATION AND WAS RELEASED. EACH CATHETER UNDERGOES FLOW AND LEAK TESTING, AND THE TENSILE FORCE AND DIMENSIONS OF THE CATHETER AND SET COMPONENTS ARE RANDOMLY CHECKED DURING MANUFACTURING PROCESS. A TWO-YEAR REVIEW OF VYGON USA'S COMPLAINT DATA INDICATES THAT THIS IS THE ONLY REPORTED COMPLAINT RELATED TO A BROKEN CATHETER FROM LOT 23B005D. CORRECTIVE ACTION: BASED ON THE INVESTIGATION, THIS DEFECT DUE MECHANICAL DAMAGE CAUSED BY A SHARP INSTRUMENT, SUCH AS SCISSORS OR A SCALPEL. ADDITIONALLY, SINCE THE CATHETER FUNCTIONED AS INTENDED FOR 24 HOURS, WE DO NOT BELIEVE THE DEFECT IS RELATED TO MANUFACTURING. ANY MANUFACTURING-RELATED ISSUES WOULD LIKELY HAVE BEEN DETECTED BY THE USER DURING THE INITIAL FLUSHING OF THE CATHETER. AS A RESULT, NO FURTHER CORRECTIVE ACTION HAS BEEN INITIATED BY VYGON GERMANY GMBH QUALITY MANAGEMENT AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE MALFUNCTIONING DEVICE WILL BE RETURNED FOR EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. UPON RECEIPT, IT WILL BE INVESTIGATED. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE REPORTED TO THE FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA A FOLLOW-UP MDR.

    Description of Event or Problem · 0

    LINE BROKE DURING DRESSING CHANGE. THE DRESSING HAD BEGUN TO LIFT UP. SECRUPORT IV GLUE WAS USED AND THE NURSE NOTED THAT THE CATHETER WAS STICKING TO THE DRESSING. NO ADVERSE EFFECTS.

    Description of Event or Problem · 0

    LINE BROKE DURING DRESSING CHANGE. THE DRESSING HAD BEGUN TO LIFT UP. SECRUPORT IV GLUE WAS USED AND THE NURSE NOTED THAT THE CATHETER WAS STICKING TO THE DRESSING. NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196774 PREMICATH INTRAVASCULAR CATHETER LJS VYGON USA 1261.203G 23B005D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown