BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPICUTANEO CAVA CATHETER

    MDR report key: 4931616 · Received July 20, 2015

    Report

    Report Number
    2245270-2015-00061
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Date of Event
    March 30, 2015
    Report Date
    July 20, 2015
    Manufacturer
    VYGON CORP.
    Product Code
    LJS
    PMA / PMN Number
    K897168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS FIRST REPORTED TO VYGON BY FDA VIA THE USER FACILITY'S MEDWATCH REPORT. THE REPORT THAT REFERENCES THIS ISSUE IS: MW5041857. ALTHOUGH THE DEVICE WAS NOT RETURNED TO VYGON, THE DETAILS OF THE COMPLAINT WILL BE FORWARDED TO THE MFR FOR COMPLAINT 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

    PREMATURE INFANT IS HOUSED IN THE NICU DUE TO A CERVICAL NECK MASS. THE INFANT WAS RECEIVING FLUIDS AND MEDICATION VIA A PICC LINE. THE PICC LINE WAS NOTED TO BE CRACKED AT THE INSERTION SITE. THE NURSE ALSO REPORTED A HOLE IN THE LINE. THE PICC LINE WAS REMOVED AND REPLACED WITH A NEW LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469253 EPICUTANEO CAVA CATHETER LONG TERM INTRAVASCULAR CATHETER LJS VYGON CORP. 2184.00 170614GE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention