MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1997-11-18 for VRV-II (STERILE) 4003103 * manufactured by Quest Medical, Inc..
[22169984]
The customer reported that the surgeon inserted the left ventricular vent and hooked up the vent line. The surgeon tested the vent line prior running the case. The valve did not suck back any fluid. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627487-1997-00016 |
| MDR Report Key | 134335 |
| Report Source | 08 |
| Date Received | 1997-11-18 |
| Date of Report | 1997-11-18 |
| Date of Event | 1997-10-27 |
| Date Mfgr Received | 1997-10-30 |
| Device Manufacturer Date | 1997-04-01 |
| Date Added to Maude | 1997-11-26 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z1628 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VRV-II (STERILE) |
| Generic Name | VACCUM RELIEF VALVE |
| Product Code | MNJ |
| Date Received | 1997-11-18 |
| Model Number | 4003103 |
| Catalog Number | * |
| Lot Number | 7783.P09 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 131265 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PARKWAY ALLEN TX 750024211 US |
| Baseline Brand Name | VRV-II VACUUM RELIEF VALVE |
| Baseline Generic Name | VACUUM RELIEF VALVE |
| Baseline Model No | 4003103 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | CARIOVASCULAR SURGICAL DEVICES |
| Baseline Shelf Life Contained | N |
| 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 | 1997-11-18 |