Device product
9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media
Z-1536-2017
Product summary
- Event
- Event 76625
- Status
- Terminated
- Classification
- Class II
- Quantity
- 71 units
- Official record key
device-enforcement:Z-1536-2017
Official wording
Reason: The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states the kit contains a 10F valved peelable introducer. The kit is packaged with a 9F valved peelable introducer. The port lumen will not fit through the introducer during the insertion procedure.
Code information: MRCTI96801 Lot# MHWQ060 S2 , UDI# 884908031232
Distribution pattern: Worldwide Distribution to PR and Panama
Derived failure modes
-
Unknown
The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states the kit contains a 10F valved peelable introducer. The kit is packaged with a 9F valved peelable introducer. The port lumen will not fit through the introducer during the insertion procedure.