MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2005-03-25 for MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE VRV-100 3R93R2 manufactured by Medtronic Perfusion Systems.
[16029920]
Product leaked during the procedure and was replaced during the case. Approximately 5cc's of patient blood loss was noted during unit change out. No ptient complication has been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184009-2005-00027 |
| MDR Report Key | 587429 |
| Report Source | 05,07 |
| Date Received | 2005-03-25 |
| Date of Report | 2005-03-02 |
| Date of Event | 2005-03-02 |
| Date Facility Aware | 2005-03-02 |
| Report Date | 2005-03-02 |
| Date Reported to Mfgr | 2005-03-02 |
| Date Mfgr Received | 2005-03-02 |
| Date Added to Maude | 2005-04-05 |
| 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 | LISA WEIK |
| Manufacturer Street | 8299 CENTRAL AVE NE |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635146694 |
| Manufacturer G1 | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Street | 7611 NORTHLAND DRIVE |
| Manufacturer City | BROOKLYN PARK MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55428 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE |
| Generic Name | VACUUM RELIEF VALVE |
| Product Code | MNJ |
| Date Received | 2005-03-25 |
| Returned To Mfg | 2005-03-08 |
| Model Number | VRV-100 |
| Catalog Number | 3R93R2 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 577276 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DRIVE BROOKLYN PARK MN 55428 US |
| Baseline Brand Name | VACUUM RELIEF VALVE |
| Baseline Generic Name | VACUUM RELIEF VALVE |
| Baseline Model No | VRV-100 |
| Baseline Catalog No | 1140333-1 |
| Baseline ID | NA |
| Baseline Device Family | VACUUM RELIEF VALVE |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K953564 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-03-25 |