BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVILYST MEDICAL/VAXCEL

    MDR report key: 3231913 · Received July 11, 2013

    Report

    Report Number
    1317056-2013-00029
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 20, 2013
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH IT HAS BEEN INDICATED THAT THE USED DEVICE WILL BE RETURNED TO NAVILYST MEDICAL, TO DATE IT HAS NOT BEEN RECEIVED. UPON RECEIPT OF THE SAMPLE/COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY NAVILYST MEDICAL'S DISTRIBUTOR IN (B)(6), DURING A PICC PLACEMENT PROCEDURE, THE HANDLES DETACHED FROM A PEEL-AWAY SHEATH WHICH WAS INSERTED INTO THE VESSEL. IT WAS NECESSARY TO UTILIZE A SNARE TO REMOVE THE SHEATH. THE PT'S CONDITION IS REPORTED AS "STABLE." IT WAS STATED THAT THE USED SHEATH WOULD BE RETURNED TO NAVILYST MEDICAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319760 NAVILYST MEDICAL/VAXCEL CATHETER, INTRAVASCULAR, THERAPEUTIC LJE NAVILYST MEDICAL NA 4580201

    Patients

    Seq Age Sex Outcome Treatment
    1