MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-05-19 for VRV-II VACUUM RELIEF VALVE 4003103 manufactured by Quest Medical, Inc..
[5813764]
The hospital contacted the manufacturer via the customer service website link that their facility has encountered multiple incidents with the vacuum relief valve over the last few months. The comments section of the form did not give any other specifics other than there were "6 vrv-ii valve failures within the past 2 months" and it gave the surgeon's phone number. There was no device lot information, patient information/complications, or other details provided. Multiple attempts to contact both the hospital and the physician have been unsuccessful. It is unknown if any devices will be returning for analysis. Reference manufacturer reports: 1649914-2015-00032 through 1649914-2015-00037 to capture the quantity of six.
Patient Sequence No: 1, Text Type: D, B5
[13296855]
Initial report from customer did not include details of the alleged incident including device lot number(s). Quest medical, inc. Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported. Quest medical, inc. Defers to the patient's physician regarding medical history.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2015-00033 |
| MDR Report Key | 4782894 |
| Report Source | 06 |
| Date Received | 2015-05-19 |
| Date of Report | 2015-04-21 |
| Date Mfgr Received | 2015-04-21 |
| Date Added to Maude | 2015-06-18 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. AMY CLENDENING-WHEELER |
| 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 | 2015-05-19 |
| Model Number | 4003103 |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-05-19 |