BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA CATHETER

    MDR report key: 2032538 · Received March 29, 2011

    Report

    Report Number
    2134265-2011-01045
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFA
    PMA / PMN Number
    K944290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: RECEIVED ONE APDL/10 FLEXIMA REGULAR CATHETER DEVICE LOADED WITH METAL CANNULA. THE PRODUCT LABEL WAS RETURNED TOGETHER WITH THE MYLAR SIDE OF THE ORIGINAL OPENED POUCH. THE PACKAGING CARD, DFU AND OTHER COMPONENTS WERE NOT RETURNED WITH THE DEVICE. NO RESIDUE WAS PRESENT ON THE CATHETER INDICATING THE DEVICE WAS NOT USED. THE PIGTAIL/ DISTAL END OF THE CATHETER WAS STRAIGHTENED OUT BY THE LOADED METAL CANNULA. 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 MANUFACTURING BATCH RECORD REVIEW CONFIRMED THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS DESIGN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WHEN THE FLEXIMA DRAINAGE CATHETER PACKAGE WAS OPENED, THE PACKAGE MATERIAL STUCK TO THE CATHETER TIP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS THE DEVICE WAS NOT USED IN THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WHEN THE FLEXIMA DRAINAGE CATHETER PACKAGE WAS OPENED, THE PACKAGE MATERIAL STUCK TO THE CATHETER TIP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS THE DEVICE WAS NOT USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA CATHETER TUBE, DRAINAGE, SUPRAPUBIC FFA BOSTON SCIENTIFIC - SPENCER M001271350 13440006

    Patients

    Seq Age Sex Outcome Treatment
    1