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 2018-08-07 for BACT/ALERT? BPN CULTURE BOTTLES 279045 manufactured by Biomerieux Inc..
[116909081]
A customer in (b)(6) notified biom? Rieux of poor clostridium sporogenes growth in association with the bact/alert? Bpn culture bottles (reference 279045). The customer reported that as part of each batch of biom? Rieux media bottles they preform growth promotion studies to demonstrate the bottles are capable of growing an array of microbes. The customer stated that they successfully grew all microbes in the referenced lot with the exception of clostridium sporogenes. This returned no growth in all three (3) bottles inoculated. The customer was uncertain if the poor growth was due to poor inoculation, so they repeat tested on another five bottles and received the same result of no growth. These bottles were not used for patient samples, these bottles were for quality control checks only. Since the quality control checks failed the lot was not used for routine testing. Biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00134 |
| MDR Report Key | 7759727 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-07 |
| Date of Report | 2018-08-07 |
| Date Mfgr Received | 2018-04-24 |
| Device Manufacturer Date | 2018-08-25 |
| Date Added to Maude | 2018-08-07 |
| 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. TIFFANY HALL |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| 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? BPN CULTURE BOTTLES |
| Generic Name | BACT/ALERT? BPN CULTURE BOTTLES |
| Product Code | MZC |
| Date Received | 2018-08-07 |
| Catalog Number | 279045 |
| Lot Number | 1049460 |
| Device Expiration Date | 2018-08-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-08-07 |