MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2004-05-05 for TAN 4-CHANNEL HPT CARTRIDGE 304-03 304-03AN manufactured by Medtronic Perfusion Systems.
[374862]
Info received indicates the syringe packaged with the product leaked and splashed blood on the hcp during the case. The blood was reported to be hepatitis c positive. No immediate impact to the hcp health status has been reported, and no pt involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184009-2004-00045 |
| MDR Report Key | 559059 |
| Report Source | 01,05,07 |
| Date Received | 2004-05-05 |
| Date of Report | 2004-04-06 |
| Date of Event | 2004-04-05 |
| Date Facility Aware | 2004-04-05 |
| Report Date | 2004-04-06 |
| Date Reported to Mfgr | 2004-04-06 |
| Date Mfgr Received | 2004-04-06 |
| Date Added to Maude | 2004-12-14 |
| 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 | TAN 4-CHANNEL HPT CARTRIDGE |
| Generic Name | HMS CARTRIDGE |
| Product Code | JOX |
| Date Received | 2004-05-05 |
| Returned To Mfg | 2004-04-21 |
| Model Number | 304-03 |
| Catalog Number | 304-03AN |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 548756 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR. BROOKLYN PARK MN 55428 US |
| Baseline Brand Name | TAN 4-CHANNEL HPT CARTRIDGE |
| Baseline Generic Name | HMS CARTRIDGE |
| Baseline Model No | 304-03 |
| Baseline Device Family | HMS CARTRIDGES |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 02 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K894317 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-05-05 |