MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-08 for VRV-II VACUUM RELIEF VALVE 4004203 manufactured by Quest Medical, Inc.
[96857995]
There were no patient complications resulting from the alleged incident. An investigation will be conducted and a follow-up medwatch will be submitted if additional information is received.
Patient Sequence No: 1, Text Type: N, H10
[96857996]
A report received states that the valve leaked from the top during bypass with blood loss between 30cc and 50cc. The valve was replaced. No patient complications were reported at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2018-00011 |
| MDR Report Key | 7173835 |
| Date Received | 2018-01-08 |
| Date of Report | 2018-01-18 |
| Date Mfgr Received | 2017-12-22 |
| Device Manufacturer Date | 2017-09-06 |
| Date Added to Maude | 2018-01-08 |
| 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 SUCTION CONTROL DEVICE |
| Product Code | DWD |
| Date Received | 2018-01-08 |
| Returned To Mfg | 2018-01-03 |
| Model Number | 4004203 |
| Lot Number | 054017 |
| 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 | 2018-01-08 |