BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA CATHETER

    MDR report key: 2163880 · Received July 15, 2011

    Report

    Report Number
    2134265-2011-03066
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Report Date
    June 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFA
    PMA / PMN Number
    K944290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2132465-2011-03065, 2134265-2011-03067. IT WAS REPORTED THAT DURING PREP FOR A DRAINAGE CATHETER PROCEDURE, THE PHYSICIAN FOUND THAT A PORTION OF THE PACKAGING STUCK TO THE DEVICE WHILE UNPACKING. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA CATHETER TUBE, DRAINAGE, SUPRAPUBIC FFA BOSTON SCIENTIFIC - SPENCER UNK540

    Patients

    Seq Age Sex Outcome Treatment
    1