MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-22 for RESOLVE LOCKING DRAINAGE CATHETER RLC-8-038MB/CNB manufactured by Merit Medical Systems, Inc..
[181486724]
The suspect device was not returned for evaluation. The complaint could not be confirmed. The root cause is attributed the drainage catheter implanted within the biliary system. A review of the device history and complaint database could not be performed since the lot number was not provided.
Patient Sequence No: 1, Text Type: N, H10
[181486725]
The account alleges that post-biliary drainage catheter implant, the drainage catheter tip detached within the patient after 20 days. The hospital is currently planning the surgical extraction of the detached drainage catheter tip from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010665433-2020-00003 |
| MDR Report Key | 9618620 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-22 |
| Date of Report | 2019-12-23 |
| Date of Event | 2019-12-20 |
| Date Mfgr Received | 2019-12-23 |
| Device Manufacturer Date | 2018-05-25 |
| Date Added to Maude | 2020-01-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID LOCKRIDGE |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8012084551 |
| Manufacturer G1 | MERIT MEDICAL SYSTEMS, INC. |
| Manufacturer Street | 14646 KIRBY DRIVE |
| Manufacturer City | HOUSTON TX 77047 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77047 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESOLVE LOCKING DRAINAGE CATHETER |
| Generic Name | RESOLVE DRAINAGE CATHETER |
| Product Code | GBX |
| Date Received | 2020-01-22 |
| Catalog Number | RLC-8-038MB/CNB |
| Lot Number | E1346498 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 14646 KIRBY DRIVE HOUSTON TX 77047 US 77047 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-01-22 |