BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICATH

    MDR report key: 4262129 · Received November 5, 2014

    Report

    Report Number
    2245270-2014-00094
    Event Type
    Malfunction
    Date Received
    November 5, 2014
    Date of Event
    September 21, 2014
    Report Date
    November 4, 2014
    Manufacturer
    VYGON CORP.
    Product Code
    LJS
    PMA / PMN Number
    K041468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE TWO ADD'L OCCURRENCES OF THIS CAUSE OF CONDITION IN THIS PRODUCT CODE. PLEASE REFERENCE THE FOLLOWING MDR'S FOR ADD'L INFO: MDR 2245270-2014-00092. MDR 2245270-2014-00093. ALTHOUGH THE DEVICE WAS NOT RETURNED TO VYGON THE COMPLAINT WILL BE FORWARDED TO VYGON (B)(4) FOR INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING, AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION.

    Description of Event or Problem · 1

    28GA PREMICATH PICC LINE FOUND FRACTURED AT GRADUATED HUB. NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711440 PREMICATH LONGTERM INTRAVASCULAR CATHETER LJS VYGON CORP. 1261.203G

    Patients

    Seq Age Sex Outcome Treatment
    1 56 DA