تسجيل الدخول
تسجيل جديد
الأحد - ذو الحجة 5, 1446
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-09-03-25-806
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
4Fr Single-Lumen PowerPICC Catheters
الأجهزة المتأثرة
REF: 2174108, 2194108, 6174108, 6174118, 6174335, 6174355, 6194355, 22184118, CK000375 Please refer to Appendix 1 in the attachment.
الممثل المعتمد
Becton Dickinson BV Saudi Limited Company
سبب المشكلة
It has been identified by BD three lots of resin used to extrude the tubing material exceeded the supplier’s specification for a material property called Melt Flow Index (MFI), leading to increased material fatigue leaks. Also, BD has identified two additional contributing factors to the increase in material fatigue leaks.
الإجراء التصحيحي
• Cease use of any unused affected lot numbers of 4Fr Single Lumen PowerPICC. • Identify and quarantine all unused affected lot numbers of 4Fr Single Lumen PowerPICC. • Make a note of the lot numbers and immediately destroy all unused affected units. • BD is removing all unexpired lots of 4Fr Single Lumen PowerPICC which exceed the supplier’s specification for MFI. • BD is notifying users that adhesive back securement systems are recommended. • BD is notifying users that if they do use compression style securement systems, they must be sized appropriately to accommodate the reverse taper. • BD is notifying customers to insert the catheter to as close as possible to the 0 mark, per the IFU. • BD has been updating the product IFU with cautions related to the use of compression style securement systems around the taper region of the PICC. • BD will provide product replacement or credit for all destroyed products, refer to the attachment for more information. Manufacturer action: Instructions and Removal.
المرفقات
عودة للقائمة
