Trade name: Intego CSS (SAS). ANVISA registration number: 80384380024. Risk class: II. Affected template: INT CSS. No. of lots: 50515057, 50812469, 50827615, 50837233, 50881512, 60001558, 60001864, 60003127, 60003368, 60004159, 60004454, 60005487, 60006545, 60008270, 60008271. 의 안전성 경고

Safety alert

2050

2016-10-31

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

According to the company, it has been identified that intego css (sas) used with intego pet medrad®, with a validity of 3 years, can present failures in situations of occlusion, when it is more than 1 year, from the time of manufacture. therefore, there may be a leakage of both saline and radiopharmaceutical into the ionization chamber, resulting in the application of an incomplete dose, which may require repetition of the examination and may also cause possible radiation exposure to the operator if the camera is open. it has been discovered that the cause is the insufficient or uneven application of adhesive during manufacture, resulting in a possible failure of the pvc pipe connection. internal tests showed that the failure occurred in products with use in a period of more than 1 year, causing obstruction of the css extender (sas) during injection. the most common causes of occlusion are a stopcock valve in incorrect position or closures that have not been removed from the tubes.

Classification of risk: Class III. Field action classification: Collection of products, which will be destined for destruction. Field Action Code: AS-16-RAD-06. User and patient recommendations: Users are encouraged to review their current INT CSS (SAS) inventories, identify products with more than one year of manufacture, discontinue use by quarantining them immediately, and contact the Bayer Customer Service Department, to return the product to Bayer properly.