MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,08 report with the FDA on 2015-06-07 for VRVII - CLEAR 4004203 manufactured by Quest Medical, Inc..
[5841549]
The device distributor reported an issue encountered by one of their customers using the cpbp vacuum relief valve. The valve is a vacuum relief valve that is sold bulk, non-sterile to the distributor for further processing into final sterile packs. The distributor reported that there were 3 separate incidents (no exact dates provided) but with the same lot of product. See also 1649914-2015-00041 and -00043. It was reported that the valve leaked during surgery with an approximate blood loss of 15-20 cc. The complaint stated the leakage was observed during bypass. There was no information regarding the patient provided except that there were no patient complications as a result of the alleged complaint. The device was not returned to the manfacturer for analysis.
Patient Sequence No: 1, Text Type: D, B5
[13315767]
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
[24681337]
The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2015-00042 |
| MDR Report Key | 4823293 |
| Report Source | 04,08 |
| Date Received | 2015-06-07 |
| Date of Report | 2015-07-06 |
| Date of Event | 2015-05-01 |
| Date Mfgr Received | 2015-05-08 |
| Device Manufacturer Date | 2015-01-05 |
| Date Added to Maude | 2015-06-08 |
| 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 | 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 | VRVII - CLEAR |
| Generic Name | VACUUM RELIEF VALVE II |
| Product Code | DWD |
| Date Received | 2015-06-07 |
| Model Number | 4004203 |
| Lot Number | 048183 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2015-06-07 |