BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECATH S PICC (SIL)

    MDR report key: 1992302 · Received February 8, 2011

    Report

    Report Number
    1992302
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    November 30, 2010
    Report Date
    January 28, 2011
    Manufacturer
    VYGON
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US

    Narratives

    Description of Event or Problem · 1

    PICC CATHETER USED IN NICU WAS NOTED TO BE LEAKING/BREAKING BELOW THE SECUREMENT HUB. THE PICC CATHETERS APPEAR TO BE LEAKING FROM THE SAME SITE AS THE BREAKAGE.====================== MANUFACTURER RESPONSE FOR PICC CATHETER 1.9 FR 30 CM, LIFECATH S PICC (SIL)======================PICKED UP REMAINING CATHETERS FOR CREDIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECATH S PICC (SIL) CATHETER, PICC LJS VYGON * S 0882 & 10101

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DAY