BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLER ENEMA AIR TIP

    MDR report key: 1232683 · Received November 10, 2008

    Report

    Report Number
    2411512-2008-00006
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 13, 2008
    Report Date
    January 29, 2009
    Manufacturer
    E-ZEM, INC.
    Product Code
    FGD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAVE BEEN SIMILAR INCIDENTS AT (B)(6) HOSPITAL AND ADDITIONAL INCIDENTS IN 6 OTHER (B)(6) HOSPITALS. THE TYPE OF FAULT APPEARS TO BE THE SAME ON EACH OCCASION, BARIUM FLOWS IN CORRECTLY TO THE PATIENT AND RATHER THAN FLOWING COMPLETELY OUT OF THE SAME PORTAL, SOME OF THE CONTAMINATED BARIUM FLOWS OUT OF THE BLUE SIDE ARM THROUGH THE ONE WAY VALVE. CLEAN SAMPLES OF THE SAME BATCH HAVE BEEN SENT TO EZEM FOR EXAMINATION. THE TOTAL NUMBER OF VALVE LEAKAGE COMPLAINTS WITH THIS PRODUCT FROM THE (B)(6) INCLUDING THIS EVENT HAS TOTALLED (B)(4) SINCE JULY 2006 FROM 7 HOSPITALS. THE CURRENT AVAILABLE SALES DATA WHICH ONLY COVERS THE PERIOD FROM JULY 2006 TO JUNE 2008, (B)(4). E-Z-EM (B)(4) PRODUCT SPECIALISTS MADE A VISIT TO (B)(6) HOSPITAL ON THE 20TH OCTOBER TO WATCH THE SAME INVESTIGATION AS DETAILED IN THIS REPORT TO OBSERVE HOW THE MEDICAL STAFF WERE USING THE PRODUCT WITH REFERENCE TO THE MANUFACTURER'S INSTRUCTIONS FOR USE. DURING THIS EXAMINATION, THE DEVICE AGAIN LEAKED THROUGH THE VALVE, WHEN THE BARIUM WAS BEING DRAINED FROM THE PATIENT. THE LEAKAGE WAS DESCRIBED AS MINOR, WHERE NO CONTAMINATED BARIUM SOLUTION CAME IN TO CONTACT WITH THE PATIENT OR USER. COMPANY COMMENTS: THE OBSERVED LEAKAGE OF FAECAL CONTAMINATED BARIUM AS THE DESCRIBED DISTRIBUTION MIGHT HAVE AFFECTED STAFF IN THE RADIOLOGY UNIT AND THERE COULD BE A REMOTE POSSIBILITY THAT IT MIGHT LEAD TO A SERIOUS DETERIORATION IN THE HEALTH OF INDIVIDUALS. THIS IS IN REFERENCE TO THE POSSIBILITY OF CONTAMINATED BARIUM CAUSING INFECTION TO STAFF MEMBERS. THIS CASE IS THE SAME TYPE OF INCIDENT AS NOTED IN CASE (B)(4).

    Description of Event or Problem · 1

    CASE RECEIVED FROM A RADIOLOGIST ON 10/14/2008 AND FORWARDED TO (B)(4) COMPANY REPRESENTATIVE ON 10/14/2008. A HEALTH CARE PROFESSIONAL REPORTS: ON (B)(6) 2008 IN THE MORNING, A PATIENT OF UNK DEMOGRAPHICS UNDERWENT A BARIUM ENEMA PROCEDURE FOR AN UNKNOWN INDICATION WITH A FLEXI-MILLER ENEMA AIR TIP (MODEL 9507, LOT NO. 20052372). CONTAMINATED BARIUM SPILLAGE OCCURRED, DUE TO POSSIBLY FAULTY FLEXI-MILLER AIR TIP. THE RADIOLOGIST DID NOT REPORT ANY INJURIES/HARM BY THE PATIENT AND STAFF. THE SPILLAGE WAS NOT MAJOR. THE INCIDENT RESOLVED. THE (B)(6) COMPANY REPRESENTATIVE MENTIONED (B)(4) SIMILAR INCIDENTS AT (B)(6) AND ALSO SIMILAR INCIDENTS IN OTHER HOSPITALS. THE TYPE OF FAULT APPEARS TO BE THE SAME ON EACH OCCASION: BARIUM FLOWS IN CORRECTLY AND THEN RATHER THAN FLOWING OUT OF THE SAME PORTAL, THE CONTAMINATED BARIUM FLOWS OUT OF THE BLUE SIDE ARM WITH THE ONE WAY VALVE. CLEAN SAMPLES OF THE SAME BATCH HAVE BEEN SENT TO EZEM. E-Z-EM INC ARE UNDERTAKING INVESTIGATIONS/LEAKAGE TESTS AT THE MANUFACTURING SITE, TO OBSERVE IF THE SAME FAULT CAN BE OBSERVED WITH CURRENT LOTS OF THE PRODUCT, AND TO UNDERSTAND THE CAUSES OF THE LEAKAGE THROUGH THE ONE-WAY VALVE. THERE IS A NEED TO OBTAIN FURTHER INFORMATION RELATING TO THE CURRENT PRACTICES AT THE REPORTING CENTRE, AND TO INVESTIGATE WHY THE (B)(6) COMPLAINTS ARE REPRESENTING THE ONLY COMPLAINTS RECEIVED FOR THIS PRODUCT, COMPARED TO WORLDWIDE DISTRIBUTION. A HEALTH HAZARD EVALUATION IS TO BE CARRIED OUT BY THE MANUFACTURER TO DETERMINE THE REQUIREMENT FOR A CORRECTIVE ACTION. OUTCOME: RESOLVED. FURTHER INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLER ENEMA AIR TIP ENEMA TIP FGD E-ZEM, INC. 9507 20052372

    Patients

    Seq Age Sex Outcome Treatment
    1