MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-08 for VRV II VACUUM RELIEF VALVE 4004203 manufactured by Quest Medical, Inc..
[92745730]
The event occurred in (b)(6). A similar device is distributed by (b)(4) in us. There were no patient complications resulting from the alleged issue. The device was received and evaluated via simulated use testing. No leaks were observed when the device was primed. The device started leaking at a positive pressure of 13. 11psi or 677. 98 mmhg. The device is designed to relieve pressure at negative pressure of -200 mmhg and positive pressure buildup of <1300 mmhg (avg). The device functioned as intended. Dhr review conducted showed no issues during manufacturing.
Patient Sequence No: 1, Text Type: N, H10
[92745731]
The device distributor in (b)(4) reported an issue encountered by one of their customers using the cpbp vacuum relief valve. The valve is a vacuum relief valve that is sold bulk, non-sterile to the distributor for further processing into final sterile packs. The distributor reported they received a complaint which stated the valve leaked during use. This occurred during a procedure, and the clinicians continued to use the device to complete the procedure. There were no patient complications reported as a result of the alleged issue. The device was returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2017-00076 |
| MDR Report Key | 7011812 |
| Date Received | 2017-11-08 |
| Date of Report | 2017-11-08 |
| Date of Event | 2017-06-19 |
| Date Mfgr Received | 2017-08-31 |
| Date Added to Maude | 2017-11-08 |
| 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 | TOSAN ONOSODE |
| 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 | 0 |
| Brand Name | VRV II VACUUM RELIEF VALVE |
| Generic Name | CPBP VACCUM RELIEF VALVE |
| Product Code | DWD |
| Date Received | 2017-11-08 |
| Returned To Mfg | 2017-09-26 |
| Model Number | 4004203 |
| Lot Number | 052241 |
| Device Availability | R |
| 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 | 2017-11-08 |