MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2015-03-25 for FLOQSWABS manufactured by Copan Flock Technologies S.r.l..
[5601931]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13080546]
A report was sent by the initial reporter to (b)(4). Copan diagnostics, as copan flock technologies us agent, received the report from fda on 03/02/2015 as first and sole notification of the event. An internal investigation has been performed and is presented in this section. Analysis of device history records: copan checked the internal records related to the manufacturing and controls before the release on the market of the reported product 518cs01, lot number ae3500 ((b)(4) pieces). No anomalies have been found. No other incidents on the same lot have been reported. The involved device was not returned to copan for evaluation. Mechanical swab shaft bending tests (according to release sop) have been performed on the retained samples of the reported lot on different points of the shaft, in order to test shaft resistance to breakage. All the swabs subjected to the bending tests gave conforming results on all point. An analysis of the incidence of the problem has been performed for the last 4 years: copan received (b)(4) complaints related to floqswabs breakage during sampling collection procedure. All the (b)(4) were reported to fda as mdrs. (b)(4). Considering that the internal investigation could not confirm any malfunction or defect in the device lot associated with this incident, that to our knowledge no event has led to serious medical consequences so far in similar circumstances (besides the inspection of the involved cavity) and that the failure rate is very rare, no further action is planned at this time. Copan will continue to monitor products for similar events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002444944-2015-00003 |
| MDR Report Key | 4641517 |
| Report Source | 00 |
| Date Received | 2015-03-25 |
| Date Mfgr Received | 2015-03-02 |
| Device Manufacturer Date | 2013-03-01 |
| Date Added to Maude | 2015-03-31 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | VIA F. PEROTTI 16-18 |
| Manufacturer City | BRESCIA 25125 |
| Manufacturer Country | IT |
| Manufacturer Postal | 25125 |
| Manufacturer Phone | 302687211 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOQSWABS |
| Generic Name | APPLICATOR, ABSORBENT TIPS, STERILE |
| Product Code | KXG |
| Date Received | 2015-03-25 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COPAN FLOCK TECHNOLOGIES S.R.L. |
| Manufacturer Address | VIA F PEROTTI 16-18 BRESCIA 25125 IT 25125 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-25 |