MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-07-01 for SHEEP BLOOD, 100 ML * 211946 manufactured by Becton-dickinson.
[363557]
Shipment of sheep blood was received in the lab in 2004. This is used to inoculate non-blood samples -i. E. Fluids- in blood culture media to enhance growth and provide a supplement. It was set-up as a control to determine if there were any contaminates along with the pt. Nothing was isolated until 2 weeks later a gram negative rod. Preliminary testing done in house. Suspicion of brucella. Sent to the state board of health (sboh). Sboh identified brucella species. Sboh sent to cdc for species.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1032726 |
| MDR Report Key | 542846 |
| Date Received | 2004-07-01 |
| Date of Report | 2004-07-01 |
| Date of Event | 2004-06-08 |
| Date Added to Maude | 2004-09-13 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | SHEEP BLOOD, 100 ML |
| Generic Name | * |
| Product Code | JSK |
| Date Received | 2004-07-01 |
| Model Number | * |
| Catalog Number | 211946 |
| Lot Number | 4155326 |
| ID Number | * |
| Device Expiration Date | 2004-06-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 532216 |
| Manufacturer | BECTON-DICKINSON |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-07-01 |