MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1998-04-03 for VRV-II (NON-STERILE) 4003203 * manufactured by Quest Medical, Inc..
[124271]
The customer reported that the valves appeared to be occluded. The valves failed the fluid test during set-up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627487-1998-00012 |
| MDR Report Key | 161935 |
| Report Source | 08 |
| Date Received | 1998-04-03 |
| Date of Report | 1998-04-03 |
| Date Mfgr Received | 1998-03-21 |
| Device Manufacturer Date | 1997-09-01 |
| Date Added to Maude | 1998-04-13 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VRV-II (NON-STERILE) |
| Generic Name | VACUUM RELIEF VALVE |
| Product Code | MNJ |
| Date Received | 1998-04-03 |
| Returned To Mfg | 1998-03-23 |
| Model Number | 4003203 |
| Catalog Number | * |
| Lot Number | 8024 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 157672 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PKWY. ALLEN TX 750024211 US |
| Baseline Brand Name | VACUUM RELIEF VALVE-II |
| Baseline Generic Name | ONE-WAY VALVE |
| Baseline Model No | 4003203 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | CARDIOVASCULAR |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K760894 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-04-03 |