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 2018-03-08 for BACT/ALERT? BPN CULTURE BOTTLE 279045 manufactured by Biom?rieux Inc..
[102220761]
A customer in (b)(6) notified biomerieux of leakage with a bact/alert? Bpn eu bottle (reference (b)(4)). The customer reported examining the bottle for defects and while there was no obvious cause, it was noticed that the base of the bottle was convex and once the metal seal was removed from the bottle a minor defect was seen that may have been the cause of the leak due to incomplete sealing. Due to the leakage the customer reported the event as an internal incident since they could not confirm that there has been no growth due to loss of volume (0. 8 ml). The leakage was observed at the end of incubation when the bottle was being unloaded. The leakage was under the metal ring on the bottle and had dripped over the bottles in the two racks below and over the bottles directly underneath. The customer reported no organisms in the gram stain and no growth on subculture. The broth in the bottle was not turbid. Patient impact is yet to be determined. The sample was an autologous donation. There was a delay in reporting results of four (4) days. Lab coat is standard as personal protective equipment (ppe) but without gloves to load and unload bottles. After the leak was discovered the customer used gloves to remove the all bottles from the system, and gloves, goggles and lab coat while cleaning the spillage an internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00032 |
| MDR Report Key | 7324784 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-08 |
| Date of Report | 2018-06-08 |
| Date Mfgr Received | 2018-05-22 |
| Device Manufacturer Date | 2017-06-12 |
| Date Added to Maude | 2018-03-08 |
| 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 | ST. 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 |
| 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 | 2018-03-08 |
| Catalog Number | 279045 |
| Lot Number | 1049000 |
| Device Expiration Date | 2018-06-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-03-08 |