BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE ACTION PUMPING SYSTEM CONTINUOUS FLOW

    MDR report key: 3234145 · Received July 18, 2013

    Report

    Report Number
    3005099803-2013-07106
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KOD
    PMA / PMN Number
    K870557
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL ASSESSMENT WAS PERFORMED. A BLACK HAIR APPROXIMATELY 5.8CM LONG WAS LOOSE INSIDE THE PACKAGING. THERE WAS HAIR-LIKE MATERIAL STUCK UNDER THE (B)(4) LABEL ON THE OUTSIDE OF THE POUCH. SINCE THE POUCH WAS OPENED WHEN RECEIVED, IT WAS NOT POSSIBLE TO DETERMINE IF THE HAIR WAS SEALED IN THE POUCH DURING MANUFACTURING OR IF THE HAIR FELL INTO THE POUCH AFTER THE DEVICE WAS OPENED. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THE DEFECT IS UNDETERMINABLE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND REVEALED NO ISSUES RELATED TO THE COMPLAINT. THE DHR REVIEW CONFIRMS THAT THE ACCEPTED DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SINGLE ACTION PUMPING SYSTEM CONTINOUS FLOW WAS USED DURING A TRANSURETHRAL URETEROLITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, A HAIR WAS FOUND IN THE DEVICE PACKAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333893 SINGLE ACTION PUMPING SYSTEM CONTINUOUS FLOW CATHETER, UROLOGICAL KOD BOSTON SCIENTIFIC - SPENCER M0067201010

    Patients

    Seq Age Sex Outcome Treatment
    1