MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-05-04 for FLOQSWAB 503CS01 manufactured by Copan Flock Technologies.
[44346798]
An internal investigation has been performed and is presented in this section. Analysis of device history records: copan checked the bhr related to the manufacturing and controls before the release on the market of the reported product 503cs01, lot number tvp400 ((b)(4) pieces). No anomalies have been found. This is the second incident on the same lot. The involved device was not available to be 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. The internal investigation could not confirm any malfunction or defect in the device lot associated with this incident. An analysis of the incidence of the problem has been performed from 2011 up to date: copan received (b)(4) worldwide complaints related to breakage of swab during sampling collection procedure for product containing the same type of swab. Considering all these products sold worldwide from 2011 to 2015, the failure incidence is (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
[44346799]
Copan diagnostics, as copan flock technologies us agent, became aware of the event on 04/05/2015. On the same day copan flock technologies received the complaint, which was related to swab breakage during a nasal collection. Reported complaint was: "swab breaking off in a customer's nose during a nasal swab. The customer reports that the swab broke in between the tip and the red line". On 04/07/2016 a questionnaire was sent to the hospital in which the event took place, in order to acquire more information. On 04/29/2016 the filled in questionnaire was received. According to the information provided, the event occurred on (b)(6) 2016. The applied procedure was a nasal collection to investigate suspected influenza. Involved product is flocked swab, product code 503cs01. Involved patient details: female, (b)(6) years, (b)(6) pounds, diagnosis of dementia. Patient behavior during collection was mid non-collaborative, and she was not sedated during collection. The swab broke at the first diameter change (between the tip and the red-line which indicates the molded breaking point). On (b)(6) 2016 chest x-ray and ultra sound were ordered. Concerning patient's health condition, it has been reported that no injury or changes in health status have been noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005477219-2016-00004 |
| MDR Report Key | 5629994 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-05-04 |
| Date of Report | 2016-05-04 |
| Date of Event | 2016-03-26 |
| Date Mfgr Received | 2016-04-05 |
| Device Manufacturer Date | 2014-03-24 |
| Date Added to Maude | 2016-05-04 |
| 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 | 2016-05-04 |
| Model Number | 503CS01 |
| Catalog Number | 503CS01 |
| Lot Number | TVP400 |
| Device Expiration Date | 2017-12-31 |
| 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 | 2016-05-04 |