MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 2013-02-26 for ELUTIA 7118 manufactured by Bacterin International Inc..
[3359236]
Bacterin received a complaint (bacterin complaint (b)(4)) that a portion of a bacterin elutia 24 fr silicone wound drain was found to be cracked upon it's removal from the package. The user said that she opened the 24 fr drain and saw that the blue portion had cracks in it. The user decided not to use the drain. The affected drain and the remaining drains from the box of 10 were returned to bacterin.
Patient Sequence No: 1, Text Type: D, B5
[10630559]
All released and distributed production lots of this product (pn 7118, elutia 24 fr wound drains) have been recalled under part 806 (bacterin res (b)(4)). All product (pn 7118, elutia 24 fr wound drains) at bacterin's manufacturing facility has been quarantined. No product (pn 7118, elutia 24 fr wound drains) is being distributed. Summary: the opened returned drains exhibited cracking of the blue stripe in the channel section, confirming the complainant's claims. None of the fully packaged, returned drains exhibited any channel cracking until they were manually pull-tested. The partial delamination described in (b)(4) could be recreated by pulling the channel section of the drains to a 1. 5-fold elongation. The investigation into this complaint is ongoing and will be discussed in another more comprehensive letter to file. See scanned pages.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008190422-2013-00001 |
| MDR Report Key | 2999376 |
| Report Source | 04,05,06 |
| Date Received | 2013-02-26 |
| Date of Report | 2013-02-26 |
| Date of Event | 2013-01-28 |
| Date Mfgr Received | 2013-01-28 |
| Device Manufacturer Date | 2012-05-22 |
| Date Added to Maude | 2013-04-10 |
| 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 | 664 CRUISER LN. |
| Manufacturer City | BELGRADE MT 59714 |
| Manufacturer Country | US |
| Manufacturer Postal | 59714 |
| Manufacturer Phone | 4063880480 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELUTIA |
| Generic Name | PRODUCT CODE OEI |
| Product Code | OEI |
| Date Received | 2013-02-26 |
| Returned To Mfg | 2013-01-29 |
| Model Number | 7118 |
| Catalog Number | 7118 |
| Lot Number | 011012 |
| Device Expiration Date | 2015-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BACTERIN INTERNATIONAL INC. |
| Manufacturer Address | BELGRADE MT 59714 US 59714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-26 |