BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1810718 · Received August 23, 2010

    Report

    Report Number
    1058196-2010-00227
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 29, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PRIOR TO USE THE STERILE POUCH OF THE PRODUCT (ORBIT COMPLEX FILL 5X15) WAS OPEN. OTHER PRODUCTS OF THE SAME CODE AND LOT WERE USED TO COMPLETE THE CASE WITHOUT ANY PROBLEMS. THE PRODUCT EXTERIOR BOX WAS SEALED. THERE WERE NO SIGNS THAT THE PRODUCT WAS ACCIDENTALLY OPENNED AND PUT IN THE OUTER BOX. THE PRODUCT WAS NOT EXPOSED TO EXCESSIVE HEAT, AND THE PRODUCT WAS NEW. AN OPENED BOX FOR TRUFILL DCS ORBIT 637CF0515 WAS RECEIVED INSIDE OF A PLASTIC BAG. INSIDE OF THE BOX WAS AN OPENED POUCH WITH A COIL DISPENSER THAT CONTAINS THE DEVICE. ONE OF THE SIDES OF THE INNER POUCH WAS TOTALLY OPENED AND PRESENTED NO EVIDENCE OF SEAL. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED OPEN STERILE POUCH WAS CONFIRMED DURING THE ANALYSIS. ACTIONS HAVE BEEN INITIATED VIA THE RISK MANAGEMENT PROCESS TO INVESTIGATE THE ROOT CAUSE AND DETERMINE IF ANY CORRECTIVE ACTIONS ARE NEEDED. ACTION WAS OPENED TO ADDRESS THIS FAILURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    PRIOR TO USE, IT WAS FOUND THAT THE STERILE POUCH OF THE PRODUCT (ORBIT COMPLEX FILL 5X15) WAS OPEN. OTHER PRODUCTS OF THE SAME CODE AND LOT WERE USED TO COMPLETE THE CASE WITHOUT PROBLEM. THE PRODUCT EXTERIOR BOX WAS SEALED. THERE WERE NO SIGNS THAT THE PRODUCT WAS ACCIDENTALLY OPEN AND PUT IN THE OUTER BOX. THE PRODUCT WAS NOT EXPOSED TO EXCESSIVE HEAT, AND THE PRODUCT WAS NEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT MINI COMPLEX FILL CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15104098

    Patients

    Seq Age Sex Outcome Treatment
    1