BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PI PICC KIT: 1-L 4 FR X 40 CM WITH PRELO

    MDR report key: 3932850 · Received March 11, 2014

    Report

    Report Number
    1036844-2014-00114
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 6, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    LJS
    PMA / PMN Number
    K121941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS BEING PLACED INTO THE PATIENT'S RIGHT BASILIC VEIN IN THE CT HOLDING AREA. AS THE CLINICIAN WAS PLACING THE DILATOR SHEATH OVER THE PLACEMENT GUIDE WIRE, THE SHEATH STARTED TO BREAK/PEEL APART AT THE PROXIMAL END BY THE WINGS. THIS PREVENTED IT FROM BEING FULLY INSERTED. NO UNDUE FORCE WAS APPLIED. AS A RESULT, THE CLINICIAN REMOVED THE SHEATH AND REPLACED IT WITH ONE FROM ANOTHER KIT FROM THE SAME LOT NUMBER. THE SHEATH WAS INSERTED WITHOUT ISSUE AND THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO DELAY IN TREATMENT AND NO PATIENT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146364 PI PICC KIT: 1-L 4 FR X 40 CM WITH PRELO PERIPHERALLY INSERTED CENTRAL CATHETERS LJS ARROW INTL., INC. 23F14A1229

    Patients

    Seq Age Sex Outcome Treatment
    1