MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-22 for VRV II VACUUM RELIEF VALVE 4004203 manufactured by Quest Medical, Inc..
[112568684]
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. The complaint sample will be evaluated and a follow up medwatch will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[112568685]
A report was received regarding an alleged issue encountered during use of the cpbp vacuum relief valve. The report states that the device leaked during use. There were no reported patient complications resulting from the alleged issue.
Patient Sequence No: 1, Text Type: D, B5
[132406220]
The device was evaluated and was found to have functioned as intended. The device is intended to relieve pressure at negative pressure of -150mmhg and positive pressure build up of +340mmhg (avg). During simulated use testing conducted on the complaint sample, leaking was observed from the pressure relief valve under the hood at approximately 242. 1mmhg which is within the acceptable range. To determine if the static pressure (the head height between the patient and the valve) caused the valve to leak, the valve was connected to a water inlet at head height of about 4 ft. (89mmhg). No leak was observed through the device. The valve was later subjected to lower pressure of about 12 inches of water (22. 4mmhg), no leak was observed. A dhr review was conducted and no anomalies related to the complaint condition were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2018-00061 |
| MDR Report Key | 7629647 |
| Date Received | 2018-06-22 |
| Date of Report | 2018-08-17 |
| Date Mfgr Received | 2018-06-13 |
| Date Added to Maude | 2018-06-22 |
| 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 | 2018-06-22 |
| Model Number | 4004203 |
| Lot Number | 054814 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-06-22 |