BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA BILIARY CATHETER

    MDR report key: 2141685 · Received June 27, 2011

    Report

    Report Number
    2134265-2011-02467
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    April 14, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K023870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED DEVICE ANALYSIS REVEALED THE DEVICE WAS RECEIVED IN AN UNOPENED POUCH. VISUAL EXAMINATION, PRIOR TO REMOVING THE DEVICE FROM ITS PACKAGE, OBSERVED A BEND IN THE METAL CANNULA. THE DEVICE WAS REMOVED FROM THE POUCH AND WHITE MATERIAL FROM THE PACKAGING CARD WAS ADHERED TO THE COATED SECTION OF THE CATHETER INCLUDING THE DISTAL END/PIGTAIL. THE METAL CANNULA WAS BENT APPROXIMATELY 8CM FROM THE DISTAL END OF THE CAP/HUB. THE OTHER COMPONENTS WERE INTACT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THE BEND IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. THE MOST PROBABLE ROOT CAUSE OF THE NOTED WHITE MATERIAL IS CONSIDERED DESIGN RELATED DUE TO A PACKAGING DESIGN CHANGE. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT UPON RECEIPT OF THE DEVICE, A BEND WAS IDENTIFIED ON THE DEVICE. WHEN THE DEVICE WAS RECEIVED, PRIOR TO UNPACKING, A BEND WAS NOTED IN THE METAL CANNULA. THE DEVICE WAS NOT USED. AS THERE WAS NO PATIENT INVOLVED, NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED FOREIGN MATERIAL WAS PRESENT ON THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA BILIARY CATHETER CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M001272640 13844875

    Patients

    Seq Age Sex Outcome Treatment
    1