BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICATH 1FR PICC

    MDR report key: 4047510 · Received April 7, 2014

    Report

    Report Number
    2245270-2014-00028
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Date of Event
    June 10, 2011
    Report Date
    April 3, 2014
    Manufacturer
    VYGON GMBH
    Product Code
    LJS
    PMA / PMN Number
    K041468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THIS MALFUNCTION OCCURRED IN 2011, IT IS BEING REPORTED TO FDA AS A RESULT OF A (B)(4) AUDIT OBSERVATION REGARDING MDR REPORTING GIVEN TO VYGON (B)(4) ON (B)(4) 2014. THIS COMPLAINT IS NOT CONFIRMED. THE FAULTY SAMPLE RETURNED WAS THOROUGHLY EXAMINED. IT WAS FOUND THAT THE CATHETER FRAGMENTED AT 15 CM. MICROSCOPIC INSPECTION SHOWED SIGNS OF SEVER TENSILE ELONGATION LEADING TO TENSILE FRACTURE. THE FRACTURE SURFACE TYPICALLY ROUGH, WHICH ALSO HINTS TO A SEVERE TENSILE ELONGATION, RESULTING IN TENSILE FRACTURE. THE CATHETER TUBING (CODE 35961.011, BATCH NO. 041719) USED FOR CATHETER ASSEMBLY OF THIS BATCH TOTALLY MET ITS SPEC. THIS WAS THE FIRST COMPLAINT FOR BATCH NO. 042720.

    Description of Event or Problem · 1

    DURING A CATHETER REMOVAL BY THE PHYSICIAN A 15CM FRAGMENT REMAINED IN THE PT'S LEG (CATHETER RUPTURED). CHILD WAS MOVED TO ANOTHER CLINIC FOR REMOVAL. APPROX 15CM WAS REMOVED, THE REMOVED FRAGMENT WAS DISCARDED. CATHETER DRESSING WAS DONE IN NORMAL WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210131 PREMICATH 1FR PICC PUR INTRAVASCULAR CATHETER LJS VYGON GMBH 1261.306 042720

    Patients

    Seq Age Sex Outcome Treatment
    1