MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-21 for RVL-2100 B VACUUM RELIEF VALVE 4103202 manufactured by Quest Medical, Inc..
[24681847]
Quest medical, inc. Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported. Quest medical, inc. Defers to the patient's physician regarding medical history.
Patient Sequence No: 1, Text Type: N, H10
[24681908]
The foreign (mexican) product distributor reported an issue encountered by one of their customers with the cardiovascular valve. The report stated the perfusionist attempted to investigate/isolate the source of the issue in the circuit and determined there was restricted flow in the one-way valve. As a result of the alleged issue, the patient was taken off of bypass and the valve was replaced. The report stated the procedure was completed with no patient complications. The device lot number was not recorded and is unknown at the time of this report. The device was returned to the manufacturer for analysis.
Patient Sequence No: 1, Text Type: D, B5
[27419435]
Visual inspection with and without magnification did not show any defects. The valve was attached to a roller pump for functional testing and functioned as per specification. The complaint condition could not be duplicated. The applicable lot number for the part was never provided and could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2015-00058 |
| MDR Report Key | 5022221 |
| Date Received | 2015-08-21 |
| Date of Report | 2015-09-04 |
| Date of Event | 2015-07-24 |
| Date Mfgr Received | 2015-07-24 |
| Date Added to Maude | 2015-08-21 |
| 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 | MRS. AMY CLENDENING-WHEELER |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723326338 |
| Manufacturer G1 | QUEST MEDICAL, INC. |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RVL-2100 B VACUUM RELIEF VALVE |
| Generic Name | CARDIOVASCULAR SUCTION CONTROL VALVE |
| Product Code | DWD |
| Date Received | 2015-08-21 |
| Returned To Mfg | 2015-08-04 |
| Model Number | 4103202 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-21 |