Device product

POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00005

Z-1773-2018

February 08, 2018

Class II

Product summary

Firm: Bard Peripheral Vascular Inc
Event: Event 79841
Status: Completed
Classification: Class II
Quantity: 10 units
Official record key: device-enforcement:Z-1773-2018

Official wording

Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.

Code information: Lot Number Unique Device Identifier (UDI) REAN0056 (01)00801741110894(17)170628(10)REAN0056 REAN0203 (01)00801741110894(17)170628(10)REAN0203 REAP0773 (01)00801741110894(17)170728(10)REAP0773 REBN0925 (01)00801741110894(17)180131(10)REBN0925

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.