MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-08-19 for BACT/ALERT? FA PLUS BLOOD CULTURE BOTTLE 410851 manufactured by Biomerieux Inc..
[188990425]
A customer in the united states notified biom? Rieux of sample leakage in association with the bact/alert? Fa plus culture bottle. The customer reported that one fa plus bottle was cracked near the bottom of the bottle, near the location of the sensor. The bottle had been sent to the lab using a pneumatic tube system without padding around the bottles. Blood leaked into the instrument, but no other blood culture bottles were contaminated by the sample. When removing the bottle, a lab technician was exposed to the leaking blood sample as she was not wearing gloves. The user's intact skin was exposed to the sample, and she washed her hands immediately. There was no medical treatment as a result of this exposure. There was no mucous membrane or cut on the user's skin that was exposed to the patient sample. The customer reported that the broken bottle was rejected for further testing and would be recollected from the patient. There is no indication of delayed results from the laboratory. The patient had another set of bottles being tested. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2019-00050 |
| MDR Report Key | 8908017 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-08-19 |
| Date of Report | 2019-08-19 |
| Date Mfgr Received | 2019-07-21 |
| Device Manufacturer Date | 2019-03-03 |
| Date Added to Maude | 2019-08-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CANDACE MARTIN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX INC. |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27712 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT? FA PLUS BLOOD CULTURE BOTTLE |
| Generic Name | BACT/ALERT? FA PLUS BLOOD CULTURE BOTTLE |
| Product Code | MDB |
| Date Received | 2019-08-19 |
| Catalog Number | 410851 |
| Lot Number | 4053188 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX INC. |
| Manufacturer Address | 100 RODOLPHE STREET DURHAM NC 27712 US 27712 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-19 |