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..
[92796713]
The device was not returned for evaluation. The dhr for the device was reviewed and no non-conformities or deviations were associated with the manufacturing of the device. The root cause of the issue is unknown.
Patient Sequence No: 1, Text Type: N, H10
[92796714]
The distributor reported an issue with the cpbp vacuum relief valve. This valve was integrated into a sucker line in our cardiovascular tubing kit. The report states that the valve got stuck during use by the distributor's customer and wasn't sucking any blood. This occurred during a procedure, but when they applied some pressure on the valve, it clicked and started working. There was no delay to the procedure, no patient injury, and no blood loss was reported. The device was discarded and will not be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2017-00075 |
| MDR Report Key | 7011809 |
| Date Received | 2017-11-08 |
| Date of Report | 2017-11-08 |
| Date of Event | 2017-08-30 |
| Date Mfgr Received | 2017-08-30 |
| Device Manufacturer Date | 2017-05-25 |
| 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 VACUUM RELIEF VALVE |
| Product Code | DWD |
| Date Received | 2017-11-08 |
| Model Number | 4004203 |
| Lot Number | 053717 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2017-11-08 |