MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-19 for BACTISWAB OR BACTISWAB II * 12100/12110 OR 12200/12210 manufactured by Remel.
[1733864]
Nurse has swabbed patient's throat for strep screen. When preparing the swab to send to the lab after obtaining the sample, nurse squeezed the ampoule to preserve the sample and the glass ampoule broke the outside container and cut the nurse's finger. ====================== health professional's impression======================possibly user error, may have squeezed to hard. Have not had any other reports of this occurring.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1968512 |
| MDR Report Key | 1968512 |
| Date Received | 2011-01-19 |
| Date of Report | 2011-01-19 |
| Date of Event | 2011-01-17 |
| Report Date | 2011-01-19 |
| Date Reported to FDA | 2011-01-19 |
| Date Added to Maude | 2011-01-24 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACTISWAB OR BACTISWAB II |
| Generic Name | CULTURE SWAB |
| Product Code | LIO |
| Date Received | 2011-01-19 |
| Model Number | * |
| Catalog Number | 12100/12110 OR 12200/12210 |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REMEL |
| Manufacturer Address | 12076 SANTA FE DR. LENEXA KS 66215 US 66215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-19 |