MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-04-15 for 3T MEDICAL SYSTEMS, LLC * 030NS manufactured by Geneva Medical Products.
[231121]
A defective 3t vent valve was verbally communicated to the 3t corporate office. A vent valve is a one-way valve used in a blood line during open heart surgery. The defective valve leaked a small quantity of blood as an added component to a custom tubing pack mfg and distributed by medtronic, inc. A prior "out of the box" failure occurred at the same hosp prior to using a similar device sold by 3t that leaked clinically.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1024774 |
| MDR Report Key | 389731 |
| Date Received | 2002-04-15 |
| Date of Report | 2002-04-15 |
| Date of Event | 2002-03-27 |
| Date Added to Maude | 2002-04-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3T MEDICAL SYSTEMS, LLC |
| Generic Name | ONE-WAY VENT VALVE |
| Product Code | KRI |
| Date Received | 2002-04-15 |
| Returned To Mfg | 2002-03-28 |
| Model Number | * |
| Catalog Number | 030NS |
| Lot Number | 7167789 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 378770 |
| Manufacturer | GENEVA MEDICAL PRODUCTS |
| Manufacturer Address | 100 WISCONSIN ST WALWORTH WI 53184 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-04-15 |