BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA ALL PURPOSE DRAINAGE CATHETER

    MDR report key: 1030706 · Received April 15, 2008

    Report

    Report Number
    2134265-2008-01098
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 21, 2008
    Report Date
    March 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFA
    PMA / PMN Number
    K944290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER COMPLAINT STATED THAT THE DEVICE SEEMED TO BE DAMAGED AND THE STERILITY OF THE PACKAGE MAY HAVE BEEN COMPROMISED. RECEIVED ONE FLEXIMA APDL REG 10F/25CM DEVICE IN ORIGINAL UNOPENED POUCH WITH PRODUCT LABEL. A VISUAL EVAL FOUND A TEAR IN THE MYLAR SIDE OF THE POUCH BEAR THE CHEVRON END OF THE POUCH, CLOSE TO THE 10 FR FAMILY CORNER LABEL. THE TEAR WAS CIRCLED AND MARKED WITH BLUE INK. THE TEAR MEASURED APPROX 9 MM AND THE TORN EDGES APPEARED TO HAVE SERRATIONS. EVALUATING THE RETURNED PRODUCT, IT WAS CONFIRMED THAT THE STERILITY BARRIER WAS BREACHED DUE TO A TEAR IN THE POUCH, BUT NO DAMAGE WAS FOUND IN THE DEVICE AND THE OTHER CONTENTS IN THE POUCH. THE TEAR / HOLE IN THE POUCH WAS SERRATED AND APPEARED TO BE CAUSED BY THE RIBBED EDGE OF THE TROCAR CAP PRESSING AGAINST THE MYLAR SIDE OF THE POUCH DURING DISTRIBUTION/ HANDLING, BREACHING THE STERILITY BARRIER. THE MOST PROBABLE ROOT CAUSE IS HANDLING DAMAGE DURING THE DISTRIBUTION/ TRANSIT. A REVIEW OF DEVICE HISTORY RECORD (LOT NUMBER 11501481) WAS PERFORMED AND REVEALED NO RELATED ISSUES TO THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A DRAINAGE PLACEMENT PROCEDURE, THE DEVICE APPEARED TO BE DAMAGED. THE DEVICE HAD NOT BEEN USED BUT WAS NOTED TO BE AN ALL PURPOSE DRAINAGE CATHETER. IT IS UNK WHERE THE DEVICE WAS BEING USED. THE COMPLAINT REPORTER STATED THAT "IT WAS FELT THERE WERE TOO MANY ITEMS IN THE BOX, WHICH CAUSED THE DAMAGE & COMPROMISED THE STERILITY OF THE PRODUCT AT THE POUCH LEVEL." THERE WERE NO REPORTED PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA ALL PURPOSE DRAINAGE CATHETER FFA TUBE, DRAINAGE, SUPRAPUBIC FFA BOSTON SCIENTIFIC CORPORATION M001271350 11501481

    Patients

    Seq Age Sex Outcome Treatment
    1