BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA BILIARY CATHETER

    MDR report key: 2023602 · Received March 18, 2011

    Report

    Report Number
    2134265-2011-01000
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 19, 2011
    Report Date
    February 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K023870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RECEIVED ONE VTCB/8.3 FLEXIMA FIRM W/RO CATHETER DEVICE LOADED WITH METAL CANNULA IN ORIGINAL OPENED POUCH WITH PRODUCT LABEL TOGETHER WITH OTHER RELATED COMPLAINT DEVICES. ALL THE 8 DEVICES WERE RETURNED, STUFFED INSIDE ONE UMD BOX. THE PACKAGING CARD AND DFU WAS NOT RETURNED. NO RESIDUE WAS PRESENT ON THE BILIARY CATHETER OR ITS COMPONENTS INDICATING THE DEVICE WAS NOT USED. FROM A VISUAL EVALUATION, IT WAS FOUND THAT WHITE MATERIAL WAS STUCK TO COATED SECTION OF THE CATHETER INCLUDING THE DISTAL END/PIGTAIL THAT WAS IN CONTACT WITH THE PACKAGING CARD. THE METAL CANNULA WAS FOUND TO BE BENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS DESIGN RELATED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#2134265-2011-00999 AND #2134265-2011-01001. IT WAS REPORTED THAT WHILE UNPACKING FOR A DRAINAGE PROCEDURE FOREIGN MATERIAL WAS NOTED. WHILE UNPACKING THE FLEXIMA DEVICE, THE CATHETER WAS NOTED TO BE "STUCK" TO THE INSIDE PAPER CARDBOARD OF THE PACKAGING. 2 ADDITIONAL CATHETERS WERE OPENED AND HAD THE SAME ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE CUSTOMER ONLY OPENED 2 OF THE CATHETERS, NOT 3 AS INITIALLY REPORTED. THE CUSTOMER ALSO RETURNED 5 ADDITIONAL DEVICES THAT CONTAINED THE SAME ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA BILIARY CATHETER CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M001272640 0013717718

    Patients

    Seq Age Sex Outcome Treatment
    1