BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLER ENEMA AIR TIP

    MDR report key: 1218867 · Received October 31, 2008

    Report

    Report Number
    2411512-2008-00005
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 31, 2008
    Manufacturer
    E-Z-EM, INC.
    Product Code
    FGD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAVE BEEN SIMILAR INCIDENTS AT THE HOSPITAL AND ADDITIONAL INCIDENTS IN SOME OTHER HOSPITALS. THE TYPE OF FAULT APPEARS TO BE THE SAME ON EACH OCCASION; BARIUM FLOWS IN CORRECTLY TO THE PT 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 ANOTHER COUNTRY INCLUDING THIS EVENT A TOTAL SINCE 2006 FROM HOSPITALS. THE CURRENT AVAILABLE SALES DATA WHICH ONLY COVERS THE PERIOD FROM JULY 2006 TO JUNE 2008, RECORDS THAT A TOTAL UNITS OF THIS DEVICE WERE SOLD, DURING THIS PERIOD, THE TOTAL COMPLAINTS WERE RECEIVED DURING THIS PERIOD, GIVING A COMPLAINT REPORTING RATE DURING THIS PERIOD OF 0.011%. THIS PRODUCT IS ALSO DISTRIBUTED TO OTHER EU COUNTRIES AND INTERNATIONAL MARKETS, WHERE COMPLAINTS REPRESENT THE ONLY COMPLAINTS RECEIVED DURING THE PERIOD, 2006 TO 2008. THE TOTAL NUMBER OF WORLD-WIDE SALES FOR THIS UNIT DURING THIS PERIOD, GIVING A COMPLAINT REPORTING RATE OF 0.006%. CO PRODUCT SPECIALISTS MADE A VISIT TO THE 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 PT. THE LEAKAGE WAS DESCRIBED AS MINOR, WHERE NO CONTAMINATED BARIUM SOLUTION CAME IN TO CONTACT WITH THE PT OR USER.

    Description of Event or Problem · 1

    NARRATIVE: CASE RECEIVED FROM A RADIOLOGIST IN EARLY 2008 AND FORWARDED TO PHARMACOVIGILANCE (OPERATING ON BEHALF OF EZEM) BY A COMPANY REPRESENTATIVE IN 2008. A HEALTH CARE PROFESSIONAL REPORTS: THE SAME DAY, IN THE MORNING, A PT OF UNK DEMOGRAPHICS UNDERWENT A BARIUM ENEMA PROCEDURE FOR AN UNK INDICATION WITH A FLEXI-MILLER ENEMA AIR TIP (MODEL 9507, LOT NO. 20052372) AND THE ASSOCIATED BLUE AIR BULB INSUFFLATOR (MODEL 9525). CONTAMINATED BARIUM SPILLAGE OCCURRED, DUE TO POSSIBLY FAULTY FLEXI-MILLER AIR TIP. THE TIP LEAKED FLUID BACK THROUGH THE ONE-WAY AIR ADMISSION VALVE, LEAKING CONTAMINATED BARIUM ON TO THE PT, THE TABLE AND THE STAFF. THE STAFF WORE DISPOSABLE APRONS AND GLOVES. THE RADIOLOGIST DID NOT REPORT ANY INJURIES / HARM BY THE PT AND STAFF. NO REMEDIAL ACTION WAS REQUIRED, APART FROM REMOVAL OF CONTAMINATED BARIUM. THE EXAMINATION WAS CONTINUED AND COMPLETED. THE INCIDENT RESOLVED. AS DEVICE WAS CONTAMINATED FROM USE WITH PT, IT WAS DISPOSED OF AFTER USING DURING THE EXAMINATION. UNUSED DEVICES FROM THE SAME LOT WERE REMOVED, TO BE RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. THE BRACCO COMPANY REPRESENTATIVE MENTIONED 9-10 SIMILAR INCIDENTS AT HINCHINGBROOKE AND ALSO SIMILAR INCIDENTS IN OTHER HOSPITALS. THE TYPE OF FAULT APPEARS TO BE THE SAME ON EACH OCCASION: BARIUM FLOWS IN CORRECTLY AND THEM 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 UK COMPLAINTS ARE REPRESENTING THE ONLY COMPLAINTS RECEIVED FOR THIS PRODUCT, COMPARED TO WORLDWIDE DISTRIBUTION. A HEALTH EVALUATION IS TO BE CARRIED OUT BY THE MANUFACTURER TO DETERMINE THE REQUIREMENT FOR A CORRECTIVE ACTION. OUTCOME: RESOLVED. FOLLOW UP INFORMATION IS REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1