Device product
Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
Z-0866-2013
Product summary
- Event
- Event 64202
- Status
- Terminated
- Classification
- Class II
- Quantity
- 387 units
- Official record key
device-enforcement:Z-0866-2013
Official wording
Reason: A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
Code information: Lot numbers H399931S1; H411376; H399938S1; H411373; H399940S1; H411374; H399942S1; H411375; H399948S1; H411380; H399950S1; H411377; H39952S1; H411378; H39953S1; H411379.
Distribution pattern: Worldwide Distribution - USA including the states of NJ, FL, GA, MO, AZ, UT and the country of Denmark
Derived failure modes
-
Unknown
A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.