Device product
CE17TFC CONTINUOUS EPID SET W/17G TUOHY, Material Number 332238 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.
Z-3374-2018
Product summary
- Event
- Event 80811
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20280
- Official record key
device-enforcement:Z-3374-2018
Official wording
Reason: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Code information: Batch: 61590460, 61594135, 61598572, 61601772, 61605134, 61610126, 61613471, 61615656, 61618348, 61621766
Distribution pattern: Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.
Derived failure modes
-
Unknown
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.