Device product
CE18TB CONT EPIDURAL TRAY, Material Number 332222 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-3364-2018
Product summary
- Event
- Event 80811
- Status
- Terminated
- Classification
- Class II
- Quantity
- 57820
- Official record key
device-enforcement:Z-3364-2018
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: 61601679, 61600958, 61603831, 61603833, 61607929, 61607931, 61607930, 61607933, 61607937, 61607938, 61607939, 61607934, 61607941, 61607940, 61607935, 61607932
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.