MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-12-18 for BACT/ALERT CULTURE BOTTLE manufactured by Biomerieux, Inc..
[213535]
Co received a report 2001 that a lab technician cut their finger on a broken bact/alert blood culture bottle. Co contacted the site december 2001 to collect additional details, and were informed the technician cut their finger while removing the glass bottle from the bact instrument. Blood and media from the bottle splashed into their face. The technician was given basic first aid for the cut and started on antiretroviral drugs while awaiting serological testing on the patient who's blood was in the bottle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1039284-2001-00001 |
| MDR Report Key | 367141 |
| Report Source | 05,06 |
| Date Received | 2001-12-18 |
| Date of Report | 2001-12-18 |
| Date of Event | 2001-11-12 |
| Date Mfgr Received | 2001-11-14 |
| Date Added to Maude | 2001-12-26 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TOM CLEMENT |
| Manufacturer Street | 100 RODOLPHE ST. |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer Phone | 9196202633 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT CULTURE BOTTLE |
| Generic Name | MICROBIAL GROWTH MONITER |
| Product Code | JSC |
| Date Received | 2001-12-18 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 356264 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE ST. DURHAM NC 27712 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-12-18 |