MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-27 for COPAN ESWAB 482C manufactured by Copan Italia Spa.
[107361224]
This report is a resubmission of initial report due to the records error that followed as a result of the inadvertent use of copan's registration number by becton dickinson (bd). Medwatch mdr submission (b)(4) was sent by the initial reporter to fda. The medwatch was received by copan diagnostics, as copan (b)(4) us agent, from (b)(6) on (b)(6) 2017 in the mailbox as first and sole notification of the event. Copan (b)(4) reviewed the device history record related to the manufacturing and controls before the release on the market of the reported product code 482c lot 9m2g02 (b)(4). No deviations have been recorded during the production of the claimed lot of the product. On (b)(4) 2017, customer was asked for the claimed piece for evaluation and analysis; on 21/ aug/2017, copan (b)(4) received the sample and after visually inspection the defect was confirmed. Retains sample of the same lot have been visually inspected and all the pieces were conforming (no foreign matter in the medium). An analysis of the incidence of the problem has been performed from july 2012 up to date (5 years): this is the first notification of this kind received on the product family (eswab). Considering all these products sold worldwide from 2012 to 2017, the failure incidence is less than (b)(4). Copan (b)(4) has in-place a pest control program that includes monthly inspections and periodical audits. Pest control inspection reports related to the production period have been reviewed and the results are always within the established threshold. Considering the result of the internal investigation, the extremely low defective ratio, the pest control policy already in place and that to our knowledge no adverse events would occur in similar circumstances, no further actions is planned at this time. Anyway, copan will continue to monitor products for similar events. Copan (b)(4) sent by mail a paper medwatch form as follow up to user mdr submission (b)(4) to (b)(6) mailbox on (b)(6) 2017. The paper form was not accepted by (b)(4) requiring to submit the form electronically. The follow-up to user mdr submission (b)(4) here is submitted by emdr submission 3002444944-2017-00001.
Patient Sequence No: 1, Text Type: N, H10
[107361225]
The eswab was laying on the counter, clear back side facing up. A bug was noticed to be floating in the fluid. Package unopened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002444944-2017-00001 |
| MDR Report Key | 7467704 |
| Date Received | 2018-04-27 |
| Date of Report | 2017-07-25 |
| Date of Event | 2017-06-08 |
| Date Mfgr Received | 2017-07-25 |
| Device Manufacturer Date | 2016-07-07 |
| Date Added to Maude | 2018-04-27 |
| 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 STEFANIA TRIVA |
| Manufacturer Street | VIA F. PEROTTI 10 |
| Manufacturer City | BRESCIA, ITALY 25125 |
| Manufacturer Country | IT |
| Manufacturer Postal | 25125 |
| Manufacturer G1 | COPAN ITALIA SPA |
| Manufacturer Street | VIA F. PEROTTI 10 |
| Manufacturer City | BRESCIA, LOMBARDIA 25125 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 25125 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COPAN ESWAB |
| Generic Name | COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM |
| Product Code | JTW |
| Date Received | 2018-04-27 |
| Returned To Mfg | 2017-08-31 |
| Model Number | 482C |
| Catalog Number | 482C |
| Lot Number | 9M2G02 |
| Device Expiration Date | 2017-09-30 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COPAN ITALIA SPA |
| Manufacturer Address | VIA F. PEROTTI 10 BRESCIA, LOMBARDIA 25125 IT 25125 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-27 |