Device product
Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.
Z-2266-2019
Product summary
- Event
- Event 83287
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200
- Official record key
device-enforcement:Z-2266-2019
Official wording
Reason: 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body
Code information: Lot Code: P1841839
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body