MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2008-10-31 for MILLER ENEMA AIR TIP 9507 manufactured by E-z-em, Inc..
[968465]
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.
Patient Sequence No: 1, Text Type: D, B5
[8229542]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2411512-2008-00005 |
| MDR Report Key | 1218867 |
| Report Source | 01,05,06,07 |
| Date Received | 2008-10-31 |
| Date of Report | 2008-10-31 |
| Date of Event | 2008-10-01 |
| Date Mfgr Received | 2008-10-01 |
| Device Manufacturer Date | 2008-01-02 |
| Date Added to Maude | 2009-06-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SINAI DAVIS, MD |
| Manufacturer Street | 107 COLLEGE ROAD EAST |
| Manufacturer City | PRINCETON NJ 08540 |
| Manufacturer Country | US |
| Manufacturer Postal | 08540 |
| Manufacturer Phone | 8002575181 |
| Manufacturer G1 | E-Z-EM, INC. |
| Manufacturer Street | 750 SUMMA AVE. |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11590 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MILLER ENEMA AIR TIP |
| Generic Name | ENEMA TIP |
| Product Code | FGD |
| Date Received | 2008-10-31 |
| Model Number | 9507 |
| Catalog Number | NI |
| Lot Number | 20052372 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | E-Z-EM, INC. |
| Manufacturer Address | 750 SUMMA AVE WESTBURY NY 11590 US 11590 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-31 |