BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST / VAXCEL

    MDR report key: 1171948 · Received September 19, 2008

    Report

    Report Number
    1317056-2008-00068
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 27, 2008
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POUCH REFERENCED IN THE REPORTED INCIDENT WAS RETURNED ALONG WITH TWO ADDITIONAL POUCHES, ALSO DAMAGED. VISUAL INSPECTION NOTED ALL POUCH SEALS TO BE INTACT. ON EACH POUCH, ON THE MYLAR SIDE, A LENGTHWISE SLICE WAS OBSERVED, APPROXIMATELY 5 IN. LONG, IN THE MIDDLE OF THE POUCH. THE CUTS WERE DEEP ENOUGH TO EXTEND INTO THE DIRECTIONS FOR USE PAMPHLETS WITHIN THE POUCHES. A DEVICE HISTORY REVIEW WAS PERFORMED ON THE REPORTED LOT NUMBER FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT IN THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOT MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. WHILE THE EXACT CAUSE OF THE DAMAGE CANNOT BE CONFIRMED, IT IS POSSIBLE THAT THE KITS WERE PACKAGED WITHOUT THE CARDBOARD SEPARATOR PLACED BETWEEN THE TOP KIT AND THE FOLDED END FLAPS OF THE INNER CARTONS. THE LOCATION OF THE DAMAGE TO THE POUCHES WOULD BE CONSISTENT WITH HOW A BOX KNIFE WOULD SLICE THE POUCHES, IF THE CARDBOARD SEPARATOR WAS NOT IN PLACE. AS CORRECTIVE ACTION, WE HAVE MADE OUR CUSTOM PACKAGING EMPLOYEES AWARE OF THIS ISSUE, AND HAVE PERFORMED RETRAINING ON THE APPLICABLE PACKAGING PROCEDURE. PACKAGING PROCESS CONTROLS INCLUDE 100% VISUALIZATION OF POUCHES FOR DAMAGE OR DEFECTS. (B) (4).

    Description of Event or Problem · 1

    AS REPORTED, DURING PREPARATION FOR A PICC PLACEMENT PROCEDURE, A SLIT WAS FOUND ON THE UNDERSIDE OF THE STERILE PRODUCT POUCH WHEN IT WAS REMOVED FROM THE CARTON. THE PRODUCT WAS NOT USED, AND THE PACKAGE WAS RETURNED FOR EVALUATION. THERE WAS NO IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST / VAXCEL VALVED PICC LJS NAVILYST MEDICAL NA 1274062

    Patients

    Seq Age Sex Outcome Treatment
    1