MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-05-18 for VRV II VACUUM RELIEF VALVE 4004203 manufactured by Quest Medical, Inc..
[109109346]
The event occurred in (b)(6) with the valve which is sold bulk, non-sterile to the customer for further processing into final sterile packs. A similar device is distributed by quest medical in us, hence this medwatch is being submitted. No complaint sample was returned for evaluation. A dhr review conducted showed no manufacturing anomalies related to the reported complaint. The root cause of the alleged issue is unknown.
Patient Sequence No: 1, Text Type: N, H10
[109109347]
A report was received regarding an alleged issue encountered during use of the cpbp vacuum relief valve. The report states that there was a leak in the sucker one way valve in the yellow aortic root vent line and they had to delay running onto bypass to cut the significantly leaking valve out of the circuit. There were no reported patient complications reported as a result of the alleged issue.
Patient Sequence No: 1, Text Type: D, B5
[132398246]
The device was not returned for evaluation and the inventory on the lot reported has been depleted. Dhr review was conducted and no anomalies, related to the complaint condition, were found. The root cause of the alleged incident is unknown. Quest medical will continue to monitor complaints for trend.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2018-00048 |
| MDR Report Key | 7527990 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-05-18 |
| Date of Report | 2018-08-17 |
| Date Mfgr Received | 2018-05-02 |
| Date Added to Maude | 2018-05-18 |
| 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 VACCUM RELIEF VALVE |
| Product Code | DWD |
| Date Received | 2018-05-18 |
| Model Number | 4004203 |
| Lot Number | 054486 OR 054814 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2018-05-18 |