MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-06-09 for BACT/ALERT? BPN CULTURE BOTTLE 279045 manufactured by Biom?rieux Inc..
[77292293]
A customer in (b)(6) notified biom? Rieux of a damaged bottle rim associated with bact/alert? Bpn culture bottle. The customer reported that a laboratory trainee had blood inside his glove and initially reported that he did not know how he had cut himself through the glove. An incident report was filed and it was reported that the laboratory trainee cut himself while practicing inoculating bottles. The customer reported that there are a number of items and procedures used in the process of inoculating bottles and were unable to determine what had caused the cut on his finger. There is no indication or report from the laboratory that the discrepant crimp on the bottle led to any adverse event related to the laboratory trainees state of health and no report of treatment for the cut was provided. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00134 |
| MDR Report Key | 6631973 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-09 |
| Date of Report | 2017-08-09 |
| Date of Event | 2017-05-23 |
| Date Mfgr Received | 2017-07-13 |
| Device Manufacturer Date | 2017-01-12 |
| Date Added to Maude | 2017-06-09 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27712 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | FCA 3522 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT? BPN CULTURE BOTTLE |
| Generic Name | BACT/ALERT? BPN CULTURE BOTTLE |
| Product Code | MZC |
| Date Received | 2017-06-09 |
| Model Number | 279045 |
| Lot Number | 1048256 |
| Device Expiration Date | 2018-01-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX INC. |
| Manufacturer Address | 100 RODOLPHE STREET DURHAM NC 27712 US 27712 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-09 |