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تسجيل جديد
السبت - جمادى الأولى 17, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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أسئلة شائعة
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EN
SA-06-11-25-1134
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Rocket Seldinger Chest Drain Kits
الأجهزة المتأثرة
Product Codes: R54544-12-SG, R54544-18-SG, R54544-12-PK, R54544-18-PK, R54549-16-PK, R54549-20-PK Please refer to the attachment for more details.
الممثل المعتمد
Modern Quality Trading Est
سبب المشكلة
The Instructions for Use (IFU) (ZDOCK180) for the devices listed above contains the instruction ‘The chest tube can now be secured to the skin by using the fixation device R54960-PG-FX or suture or both and is ready for connection to a suitable sealed drainage system such as the Rocket Blue Bottle or Rocket Ambulatory Bag’.
الإجراء التصحيحي
The IFU has been updated to include revised guidance regarding the need for a suture, in steps 14 and 15. The updated text now states: ‘The chest tube must now be secured to the skin by suture and is ready for connection to a suitable sealed drainage system such as the Rocket Blue Bottle or Rocket Ambulatory Bag. Further support to the catheter can be provided by the fixation device. Ensure the attachment and the updated IFU are available to all users. Manufacturer's Action: Instructions and Correction.
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