BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICATH

    MDR report key: 6721422 · Received July 18, 2017

    Report

    Report Number
    2245270-2017-00037
    Event Type
    Malfunction
    Date Received
    July 18, 2017
    Date of Event
    July 30, 2017
    Report Date
    September 7, 2017
    Manufacturer
    VYGON GMBH
    Product Code
    LJS
    PMA / PMN Number
    K041468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT AND RETURNED SAMPLE HAVE BEEN SUBMITTED TO VYGON (B)(6), WHICH IS WHERE THIS PART WAS MANUFACTURED, FOR EVALUATION. VYGON (B)(6) REPORTS THE FOLLOWING REGARDING THIS COMPLAINT. AS RECEIVED, THE CATHETER WAS LEAKING JUST DISTAL THE PINK ADAPTER. MICROSCOPIC INSPECTION SHOWED SIGNS THAT THE CATHETER WAS DAMAGED BY THE STYLET (LITTLE DIAGONAL RUNNING TEARS). THE CATHETER CAN COMPRESS ONTO THE STYLET DURING REMOVAL DUE TO FRICTIONAL FORCES. THE MOST PROBABLE CAUSE OF THE CATHETER LEAK IS THAT THE STYLET CUT INTO THE CATHETER'S WALL DURING THE STYLET REMOVAL. TESTS HAVE SHOWN THAT FLUSHING THE CATHETER WITH DILUTED LIPID SOLUTION WILL IMPROVE STYLET REMOVAL. NO CORRECTIVE ACTION IS WARRANTED; HOWEVER, BOTH VYGON (B)(6) AND VYGON USA HAVE ENTERED THIS INCIDENT INTO OUR COMPLAINT LOGS AND WILL CONTINUE TO BE VIGILANT FOR THIS TYPE OF COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE MALFUNCTIONING DEVICE WAS RETURN TO VYGON FOR EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE PENDING AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION VIA FOLLOW UP MDR.

    Description of Event or Problem · 1

    PICC WAS NOTICED TO BE LEAKING AT TIME OF INSERTION AFTER THE STYLET WAS REMOVED.

    Description of Event or Problem · 1

    PICC WAS NOTICED TO BE LEAKING AT TIME OF INSERTION AFTER THE STYLET WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503517 PREMICATH LONG TERM INTRAVASCULAR CATHETER LJS VYGON GMBH 1261.306G 15B001D

    Patients

    Seq Age Sex Outcome Treatment
    1