MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-11-19 for VRV-II VACUUM RELIEF VALVE 4003103 manufactured by Quest Medical, Inc.
[128073877]
The alleged incident occurred outside of the us. This medwatch is being submitted because quest distributes a similar device in the us. Evaluation of the complaint sample indicates insufficient adhesive as the root cause of the reported complaint condition. A quality alert was issued to manufacturing operators as a corrective action. Quest will continue to monitor complaint trends.
Patient Sequence No: 1, Text Type: N, H10
[128073878]
The report received states that a medical staff found the cap of the valve detached from the body. The medical staff elected to remove the valve and used another valve for the procedure. There were no patient complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2018-00092 |
| MDR Report Key | 8085254 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-11-19 |
| Date of Report | 2018-11-19 |
| Date Mfgr Received | 2018-11-06 |
| Date Added to Maude | 2018-11-19 |
| 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 | 3 |
| Brand Name | VRV-II VACUUM RELIEF VALVE |
| Generic Name | CPBP VACUUM RELIEF VALVE |
| Product Code | DWD |
| Date Received | 2018-11-19 |
| Returned To Mfg | 2018-11-13 |
| Model Number | 4003103 |
| Lot Number | 0551398J07 |
| 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 | 2018-11-19 |