MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for RENOVARP PARACENTESIS PUMP GIS-31 manufactured by Gi Supply, Inc..
[183123789]
We used a renova para kit for a para and the tubing was spitting out ascites fluid like there was a small puncture in the tubing. We opened a new kit and disconnected the problematic tubing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9824065 |
| MDR Report Key | 9824065 |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-28 |
| Report Date | 2020-02-12 |
| Date Reported to FDA | 2020-02-12 |
| Date Reported to Mfgr | 2020-03-12 |
| Date Added to Maude | 2020-03-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RENOVARP PARACENTESIS PUMP |
| Generic Name | PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) |
| Product Code | BTA |
| Date Received | 2020-03-12 |
| Model Number | GIS-31 |
| Lot Number | 9063 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GI SUPPLY, INC. |
| Manufacturer Address | 5069 RITTER ROAD SUITE 104 MECHANICSBURG PA 17055 US 17055 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-12 |