MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-16 for VRV II VACUUM RELIEF VALVE 4004203 manufactured by Quest Medical, Inc..
[93165807]
The event occurred outside of the us. A similar device is distributed by quest medical in us. There were no patient complications resulting from the alleged issue. At the time of this report, three requests for device return have been sent to the customer but the device has not been returned for evaluation. Dhr review conducted did not show any anomalies during production of the device. A follow-up medwatch will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[93165808]
A customer in (b)(6) reported an issue encountered while using the cpbp vacuum relief valve. The report states that two valves leaked during use in a hospital. The leak was noticed at the base of the dome of the valve. The valve was replaced. There were no patient complications reported as a result of the alleged issue.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1649914-2017-00093 |
MDR Report Key | 7039483 |
Date Received | 2017-11-16 |
Date of Report | 2018-01-18 |
Date Mfgr Received | 2017-10-20 |
Date Added to Maude | 2017-11-16 |
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 VACCUM RELIEF VALVE |
Product Code | DWD |
Date Received | 2017-11-16 |
Returned To Mfg | 2017-11-29 |
Model Number | 4004203 |
Lot Number | 050999 |
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 | 1. Required No Informationntervention | 2017-11-16 |