MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-19 for LEECHES BM manufactured by Ricarimpex Sas.
[39425353]
The results of routine water sampling of the dechlorinated water treatment system at the production site, performed on (b)(4) and received on (b)(4), show presence of pseudomonas aeruginosa at the distribution point for use of water in production. On (b)(4), as soon as the manufacturer became aware of the contamination, the four lots in stock were quarantined and subjected to testing for pseudomonas spp. In accordance with established procedures. In three lots, pseudomonas spp. Was detected. These three lots remain in quarantine. Repeat analysis of water, as per test results received on (b)(4), showed the water treatment system to be free of microbiological contamination, including pseudomonas aeruginosa. During the period of potential contamination of the water used in production, potentially non-conforming product from two of the contaminated lots had been sold in (b)(6). All customers who were shipped leeches during this period were notified and warned that they may have received nonconforming product. Respective product still in customer possession has been destroyed. The third contaminated lot was not distributed. Investigation of the problem has identified a technical intervention in the water system (change of filter), taking place on (b)(4) 2016, as cause of the contamination. A capa has been opened and appropriate corrective and preventive action has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009106257-2016-00001 |
| MDR Report Key | 5447120 |
| Date Received | 2016-02-19 |
| Date of Report | 2016-02-19 |
| Date Mfgr Received | 2016-01-22 |
| Device Manufacturer Date | 2015-11-05 |
| Date Added to Maude | 2016-02-19 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SONIA BARBE |
| Manufacturer Street | 245, AVENUE DE SAINT MEDARD |
| Manufacturer City | EYSINES, AQUITAINE 33320 |
| Manufacturer Country | FR |
| Manufacturer Postal | 33320 |
| Manufacturer Phone | 56578412 |
| Manufacturer G1 | RICARIMPEX SAS |
| Manufacturer Street | 245, AVENUE DE SAINT MEDARD |
| Manufacturer City | EYSINES, AQUITAINE 33320 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 33320 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LEECHES |
| Generic Name | LEECHES HIRUDO MEDICINALIS |
| Product Code | NRN |
| Date Received | 2016-02-19 |
| Model Number | BM |
| Lot Number | 15/0511/R5, 15/0411/CARD |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICARIMPEX SAS |
| Manufacturer Address | 245, AVENUE DE SAINT MEDARD EYSINES, AQUITAINE 33320 FR 33320 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-19 |