Device product
CE18TKO PERIFIX ONE EPIDURAL FULL TRAY, Material Number 332282 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-3379-2018
Product summary
- Event
- Event 80811
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22280
- Official record key
device-enforcement:Z-3379-2018
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: 61588931, 61589445, 61592524, 61609149, 61598518, 61615365, 61619575, 61620760
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.