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الاثنين - رجب 2, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-18-12-25-1188
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اسم الجهاز الطبي
basixCOMPAK™ Inflation Device
الأجهزة المتأثرة
Please refer to the attachment
الممثل المعتمد
Medical Regulations Gate
سبب المشكلة
The handle may detach from the syringe during use due to an insufficient amount of adhesive on the handle. The lack of adhesive is not detectable prior to use.
الإجراء التصحيحي
Please read and understand the following: 1. Holding the cap and barrel together during use may effectively prevent detachment. 2. Visual indicators such as pressure drops on the gauge can alert users to potential failures. Refer to the product Instructions for Use. 3. Simulated use testing showed that handle separation results in flow restoration. 4. Should the handle detach during use and the balloon not completely deflate, pull the handle out of the inflation syringe, disconnect the inflation syringe from the catheter, and use an alternate syringe to generate vacuum and aspirate residual contrast. Manufacturer Action: Instructions
المرفقات
عودة للقائمة
