BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EP-4 COMPUTERIZED STIMULATOR

    MDR report key: 2923264 · Received October 31, 2006

    Report

    Report Number
    2248049-2006-00002
    Event Type
    Injury
    Date Received
    October 31, 2006
    Date of Event
    July 15, 2005
    Report Date
    October 31, 2006
    Manufacturer
    EP MEDSYSTEMS, INC.
    Product Code
    JOQ
    Removal / Correction Number
    Z-0914-06
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE HISTORY RECORD WAS IMMEDIATELY REVIEWED AND THERE WERE NO REPORTS OF THIS TYPE OF DEFECT NOTED DURING PRODUCTION. UPON INSPECTION OF THE PHOTOGRAPHS AND AFTER READING THE REPORT THAT THE CATHETER PACKAGE WAS NOT DAMAGED AND REVIEWING THE MANUFACTURING PROCESS, THE FOLLOWING CONCLUSIONS HAS BEEN DRAWN: IT APPEARS THAT THE CATHETER WAS DAMAGED DURING THE PACKAGING PROCESS. THE DAMAGED PRODUCT WAS NOTED BY THE INSPECTOR/PACKER AND REMOVED. HOWEVER, INSTEAD OF PLACING THE PRODUCT IN THE SCRAP BIN, THE INSPECTOR MAY HAVE PLACED THE DAMAGED PRODUCT IN THE BIN OF PRODUCT THAT WAS TO BE REWORKED. THE PRODUCT WAS REMOVED FROM THE POUCH AND REPROCESSED WITHOUT THE OPERATOR NOTING THAT TIP OF THE CATHETER HAD BEEN CUT OFF BY THE SEALING EQUIPMENT. CORRECTIVE AND PREVENTIVE ACTION PLANS HAVE BEEN DEVELOPED AND ARE BEING IMPLEMENTED IN ORDER TO PRECLUDE RECURRENCE OF THIS TYPE OF EVENT.

    Description of Event or Problem · 1

    THE PATIENT REMOVED THE INTERMITTENT URINARY CATHETER FROM THE PACKAGE, APPLIED LUBRICANT TO THE TIP, INSERTED THE CATHETER INTO THE URETHRA APPROXIMATELY HALF INCH WHEN HE NOTICED A BURNING SENSATION. UPON REMOVAL OF THE CATHETER HE STARTED TO BLEED PROFUSELY AND WENT TO THE HOSPITAL EMERGENCY ROOM. UPON INSPECTION OF THE CATHETER, HE NOTED THAT THE PACKAGED WAS NOT DAMAGED, HOWEVER, THE CATHETER TIP WAS CUT AND JAGGED ON ONE PART OF IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EP-4 COMPUTERIZED STIMULATOR JOQ EP MEDSYSTEMS, INC. EP-4-2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention