BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PI PICC KIT: 2-L 5 FR X 55 CM WITH PRELO

    MDR report key: 5177389 · Received October 26, 2015

    Report

    Report Number
    1036844-2015-00502
    Event Type
    Malfunction
    Date Received
    October 26, 2015
    Date of Event
    October 21, 2015
    Report Date
    October 21, 2015
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    LJS
    PMA / PMN Number
    K121941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS BEING PLACED INTO THE PATIENT'S RIGHT BASILIC VEIN IN THE MED SURG UNIT. THE CLINICIAN WAS PULLING THE TABS OF THE SHEATH WHEN BOTH OF THEM DETACHED. THE CLINICIAN WAS ABLE TO USE HER FINGERS TO PEEL THE SHEATH BODY OFF OF THE CATHETER WHICH IT WAS STUCK TO. SHE THEN REPOSITIONED THE PICC WITHOUT THE SHEATH AND OBTAINED A BLUE BULLSEYE ON THE VPS CONSOLE WHICH RESULTED IN CAJ CATHETER PLACEMENT. THE TIP LOCATION WAS CONFIRMED WITH A CHEST X-RAY. THERE WAS NO DELAY IN TREATMENT AND NO PATIENT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707875 PI PICC KIT: 2-L 5 FR X 55 CM WITH PRELO PERIPHERALLY INSERTED CATHETER PRODU LJS ARROW INTERNATIONAL INC. 23F14K1473

    Patients

    Seq Age Sex Outcome Treatment
    1