BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENEMA ADM UNIT -BAG /SOAP/PAD

    MDR report key: 1702431 · Received May 18, 2010

    Report

    Report Number
    1423507-2010-00027
    Event Type
    Death
    Date Received
    May 18, 2010
    Date of Event
    March 16, 2010
    Report Date
    May 17, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FCE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RECEIVED FOR EVAL; THEREFORE, WE ARE UNABLE TO CONFIRM THE ISSUE REPORTED. THE PVC TUBING IS DESIGNED AND VALIDATED FOR PT USE. THE CURRENT RIGIDITY OF PVC TUBING AND SHAPE, FACILITATES THE ENEMA ADMINISTRATION UNDER SUPERVISION OF MEDICAL STAFF. THE DEVICE MASTER RECORD AND DEVICE HISTORY RECORDS FOR THE LOTS REPORTED INDICATE THAT THE COMPLETE MFG PROCESSES AND INSPECTIONS SHOWED NO ISSUES. THE EQUIPMENT, PROCESSES AND PARTS USED IN THE MFR OF THIS PRODUCT WERE VERIFIED AND CONFORM TO THE PRODUCT SPECIFICATIONS. BASED ON THE INFO THAT HAS BEEN REVIEWED THERE IS NO INDICATION OF ANY PRODUCT FAILURE, THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    RECTAL PERFORATION FOLLOWED WITH LIQUID EXTRAVASATION PERITONEAL OF THE PT. PROBE TIP COULD HAVE BEEN DEFECTIVE CAUSING THE PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENEMA ADM UNIT -BAG /SOAP/PAD ENEMA ADM UNIT -BAG /SOAP/PAD FCE CARDINAL HEALTH 6010G 0100545

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| R