MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-04-26 for FLOQSWAB 503CS01 manufactured by Copan Flock Technologies.
[43664203]
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 503cs01, lot number n4ep00 ((b)(4) pieces). No anomalies have been found. This is the first event received on the same lot. The involved device was not returned to copan for evaluation. Mechanical swab shaft bending tests (according to released sop) have been performed on the retained samples of the reported lot on the point where the breakage occurred, in order to test shaft resistance to breakage. All the swabs subjected to the bending tests gave conforming results. An analysis of the incidence of the problem has been performed from 2011 up to date: (b)(4). Considering that the internal investigation could not confirm any malfunctions/defects 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 (breakage of the swab during collection) and that the incidence rate is very rare, no corrective actions is planned at this time. An ongoing improvement on the product in order to reduce the already very low incidence rate of swab breakage is opened. Copan will continue to monitor products for similar events. Device not available.
Patient Sequence No: 1, Text Type: N, H10
[43664204]
The event occurred in (b)(6) but the same product code is distributed in usa. On (b)(6) 2016 copan (b)(4) received an email from its distributor (b)(4) saying that: "when a pediatrician of the (b)(6) hospital tried to collect samples from nasal of patient by 502cs01 regular flocked swab, the end of applicator (at a place in a range of thinner part) is broken and the remains is still left in the body (nose). " copan replied to the distributor the same day of the event notification (03/29/2016) asking for more information. On the same day (03/29/2016) the distributor only gave the information that "about the child, we are informed that there isn't any problem for the moment" on 04/01/2016 we solicited our distributor and on 04/04/2016 we received the following additional information: "the broken part was detected from stools of the patient". On 08/04/2016 and then on 13/04/2016 we solicited our distributor again to gather complete information about the event; we received an answer by email from our distributor on 04/18/2016. The information provided clarified that the product code was 503cs01 and that the product lot was n4ep00. More information were also provided: on "(b)(6) 2016, taken the swab out from the peal pouch, and used for the patient ((b)(6) child) inserted in nasal passages and pulled up. Swab was broken at the point where the thickness of the swab axis varies (approximately 7 centimeters from the tip). The doctor couldn't see any particular abnormalities and observed that process. On (b)(6), the broken part was discovered from the stools of the patient. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005477219-2016-00003 |
| MDR Report Key | 5608221 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-04-26 |
| Date of Report | 2016-04-26 |
| Date of Event | 2016-03-29 |
| Date Mfgr Received | 2016-03-29 |
| Device Manufacturer Date | 2014-03-24 |
| Date Added to Maude | 2016-04-26 |
| 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 16-18 |
| Manufacturer City | BRESCIA, ITALY 25125 |
| Manufacturer Country | IT |
| Manufacturer Postal | 25125 |
| Manufacturer Phone | 9030268725 |
| Manufacturer G1 | COPAN FLOCK TECHNOLOGIES |
| Manufacturer Street | VIA F. PEROTTI 16-18 |
| Manufacturer City | BRESCIA, ITALY 25125 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 25125 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOQSWAB |
| Generic Name | APPLICATOR, ABSORBENT TIP, STERILE |
| Product Code | KXG |
| Date Received | 2016-04-26 |
| Model Number | 503CS01 |
| Catalog Number | 503CS01 |
| Lot Number | N4EP00 |
| Device Expiration Date | 2017-03-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COPAN FLOCK TECHNOLOGIES |
| Manufacturer Address | VIA F. PEROTTI 16-18 BRESCIA, ITALY 25125 IT 25125 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-26 |