MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-27 for VRV-II VACUUM RELIEF VALVE 4003203 manufactured by Quest Medical, Inc..
[61198081]
The complaint sample was visually inspected with no anomalies found. To simulate the reported complaint condition, the valve was connected to heise gauge and tested at roller pump speed of 0. 5l/min, 1l/min and 2l/min. At all speeds the valve opened at negative pressure of 149mmhg and positive pressure of 342mmhg. The reported complaint condition could not be duplicated. The device history records for the applicable lot of product were reviewed and the inspection report showed that no defect was found and rejected and no specific manufacturing yield issue was reported similar to this complaint condition. 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
[61198082]
The international distributor ((b)(4)) reported an issue encountered by the customer when using the vacuum relief valve. The report stated that the valve "wouldn't allow air through to provide pressure relief and blood flow through was poor". Follow-up with the complainant found that they removed the device from use and replaced it with another. There was no additional blood loss from the usual the change out of valve prolonged the procedure by approximately 5 minutes. There were no patient complications reported as a result of the alleged issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2016-00063 |
| MDR Report Key | 6128194 |
| Date Received | 2016-11-27 |
| Date of Report | 2016-10-28 |
| Date of Event | 2016-10-28 |
| Date Mfgr Received | 2016-10-28 |
| Device Manufacturer Date | 2015-10-12 |
| Date Added to Maude | 2016-11-27 |
| 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 | 0 |
| Brand Name | VRV-II VACUUM RELIEF VALVE |
| Generic Name | CPBP SUCTION CONTROL DEVICE |
| Product Code | DWD |
| Date Received | 2016-11-27 |
| Returned To Mfg | 2016-11-07 |
| Model Number | 4003203 |
| Lot Number | 050044 |
| 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 | 1. Required No Informationntervention | 2016-11-27 |