MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-15 for ELUTIA WOUND DRAIN 19/24FR WOUND DRAIN 7110 manufactured by Bacterin International Inc..
[4544691]
Inadvertent omission of quarterly (q4-2013 and q1- 2014) dose audits/verifications on listed affected products. All of the affected products were sterilized appropriately per internal procedures at validated terminal gamma irradiation doses despite the omission of the dose audits.
Patient Sequence No: 1, Text Type: D, B5
[12104767]
Additional catalog, lot, catalog# 7118, lot: 028113,016913,028213. Additional manufacture date: 01/27/2014 and 01/28/2014.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005168462-2014-00014 |
| MDR Report Key | 3881843 |
| Date Received | 2014-05-15 |
| Date of Report | 2014-05-14 |
| Date of Event | 2014-05-07 |
| Device Manufacturer Date | 2013-12-11 |
| Date Added to Maude | 2014-07-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 600 CRUISER LN. |
| Manufacturer City | BELGRADE MT 59714 |
| Manufacturer Country | US |
| Manufacturer Postal | 59714 |
| Manufacturer G1 | BACTERIN INTERNATIONAL INC. |
| Manufacturer Street | 600 CRUISER LN. |
| Manufacturer City | BELGRADE MT 59714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 59714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELUTIA WOUND DRAIN |
| Generic Name | DRAINAGE CATHETER |
| Product Code | OEI |
| Date Received | 2014-05-15 |
| Model Number | 19/24FR WOUND DRAIN |
| Catalog Number | 7110 |
| Lot Number | 028013 |
| ID Number | NA |
| Device Expiration Date | 2017-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BACTERIN INTERNATIONAL INC. |
| Manufacturer Address | 664 CRUISER LANE BELGRADE MT 59714 US 59714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-15 |