Device product
CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy Cat. No. MP1000-C
Z-0049-2020
Product summary
- Event
- Event 82970
- Status
- Terminated
- Classification
- Class II
- Quantity
- 115,200
- Official record key
device-enforcement:Z-0049-2020
Official wording
Reason: After disconnection of a luer, the valve of the connector remains recessed; not fully closing, either temporarily or permanently. The risks of blood loss and air embolism exist if the valve remains permanently open and goes undetected, especially in the neonate population.
Code information: Lot Number: 18085990; Exp. Date: 15-Aug-2023 UDI: 10885403223228
Distribution pattern: Nationwide Foreign: Canada
Derived failure modes
-
Unknown
After disconnection of a luer, the valve of the connector remains recessed; not fully closing, either temporarily or permanently. The risks of blood loss and air embolism exist if the valve remains permanently open and goes undetected, especially in the neonate population.