BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA BILIARY CATHETER

    MDR report key: 2023601 · Received March 18, 2011

    Report

    Report Number
    2134265-2011-01001
    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 INCLUDING ALL ITS COMPONENTS IN THE ORIGINAL UNOPENED POUCH WITH PRODUCT LABEL TOGETHER WITH OTHER RELATED COMPLAINT DEVICES. ALL THE 8 DEVICES WERE RETURNED, STUFFED INSIDE ONE UMD BOX. THE ORIGINAL PRODUCT POUCH WAS NOT OPENED INDICATING THE DEVICE WAS NOT USED. THE DIRECTIONS FOR USE (DFU) WAS ATTACHED TO THE OUTSIDE OF THE POUCH. FROM A VISUAL EVALUATION, IT WAS FOUND THAT THE CATHETER WAS STUCK TO THE PACKAGING CARD INSIDE THE ORIGINAL UNOPENED POUCH. OPENING THE POUCH, IT WAS FOUND THAT THE COATED SECTION OF THE CATHETER INCLUDING SECTIONS OF THE DISTAL END/PIGTAIL WAS STUCK TO THE PACKAGING CARD (INSERT) WHICH IS PACKAGED INSIDE THE POUCH WITH THE CATHETER. SEPARATING THE CATHETER FROM THE PACKAGING CARD, THE WHITE MATERIAL FROM THE PACKAGING CARD ADHERED TO COATED SECTIONS OF THE CATHETER. THE METAL CANNULA WAS FOUND TO BE BENT LIKELY FROM HANDLING. 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

    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.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#2134265-2011-00999 AND #2134265-2011-01000. 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.

    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