MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-07-20 for SAF-T HOLDER BLOOD CULTURE DEVICE manufactured by Smiths Medical.
[17870195]
Staff nurse was using the saf-t holder blood culture device. When she removed a blood culture tube, the rubber over the needle came off. In a reaction to stop the bleeding, she put her thumb up and experienced a needlestick.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5003132 |
| MDR Report Key | 885253 |
| Date Received | 2007-07-20 |
| Date of Report | 2007-07-12 |
| Date of Event | 2007-05-15 |
| Date Added to Maude | 2007-08-08 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAF-T HOLDER BLOOD CULTURE DEVICE |
| Generic Name | NONE |
| Product Code | GJE |
| Date Received | 2007-07-20 |
| Lot Number | 1113155 |
| Device Expiration Date | 2010-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 867426 |
| Manufacturer | SMITHS MEDICAL |
| Manufacturer Address | KEENE NH 03431 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-07-20 |