Device product
CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY, Material Number 332077 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-3331-2018
Product summary
- Event
- Event 80811
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60760
- Official record key
device-enforcement:Z-3331-2018
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: 61595534, 61596125, 61601680, 61604904, 61607912, 61607913, 61607914, 61607915, 61607911, 61607916, 61607917, 61607918, 61607921, 61609180, 61610345, 61607922, 61607919, 61607920
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.