Drainage Catheter With Antibiotic
General, Plastic Surgery · 21 CFR 878.4780
A tubular drain made from silicone or similar material and is coated with a silver containing material and is intended to drain fluids from body cavities using gravity drainage or attached to a suction pump.
Recent MDR events
5 adverse event reports on file
- BARD CHANNEL DRAIN, 19 FR. ROUND HUBLESS FULL FLUTED, SILICONE.Nov 3, 2017C.r. Bard, Inc.MW5073113
- EXPEL¿ MULTO-PURPOSE DRAINAGE CATHETERSep 26, 2017MalfunctionBoston Scientific Corporation6893949
- MEDTRONIC VENTRICLEAR II VENTRICULAR DRAINAGE CATHETERMar 24, 2015MalfunctionMedtronic Neurological TechnologiesMW5041741
- ELUTIA WOUND DRAINMay 15, 2014MalfunctionBacterin International Inc.3005168462-2014-00014
- ELUTIAFeb 26, 2013MalfunctionBacterin International Inc.3008190422-2013-00001
Event type breakdown
Recalls
2 recall events for this product code
- Bacterin International, Inc.TerminatedJun 2, 2014
Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***"
The recalling firm reported there was inadvertent omission of quarterly (Q4 - 2013 and Q1 - 2014) dose audits/verifications on the affected products. All of the affected products were appropriately sterilized
Z-1680-2014 · View FDA record ↗ - Bacterin International, Inc.TerminatedMar 11, 2013
Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. In
A portion of a silicone wound drain was found to be cracked.
Z-0936-2013 · View FDA record ↗
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
1 clearances for this product code