BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PER-Q-CATH PLUS PICC 2F BASIC TRAY (SINGLE-LUMEN) 30CM)

    MDR report key: 3527854 · Received December 12, 2013

    Report

    Report Number
    3006260740-2013-00530
    Event Type
    Injury
    Date Received
    December 12, 2013
    Report Date
    November 19, 2013
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K954104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR, AT THIS TIME, FOR EVAL. A LOT HISTORY REVIEW (LHR) OF REUK1223 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ORDER WAS RECEIVED TO REMOVE THE PICC, (B)(6), 2013. THE PICC WAS REMOVED AS PER POLICY & PROCEDURE BY 2 RN'S, SLOWLY AND GENTLY AS DISCUSSED ON CLINICAL ROUNDS. AFTER REMOVAL, THE LINE WAS MEASURED AND NOTED THAT THE TIP PLUS 1.5CM OF THE CATHETER WAS NOT INTACT. (10.5CM PULLED OUT WHEN IT WAS INSITU 12 CM). DOCTOR WAS NOTIFIED IMMEDIATELY AND 2 VIEW X-RAYS OBTAINED FOR MISSING PICC TIP. UNABLE TO VISUALIZE. AN ECHOCARDIOGRAM WAS ALSO PERFORMED. THE REPORTED NOTED NO DETERIORATION IN PATIENT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649846 PER-Q-CATH PLUS PICC 2F BASIC TRAY (SINGLE-LUMEN) 30CM) LJS C.R. BARD, INC. (BASD) REUK1223

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention