MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-11-16 for FLOQSWAB 503CS01 manufactured by Copan Flock Technologies.
[59976920]
An internal investigation has been performed: 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 yudc00 ((b)(4) pieces). No anomalies have been found. This is the second event received on the same lot. The involved device was returned to copan for evaluation but was not analyzed due to biosafety reasons. 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: copan received 15 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 half 2016 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.
Patient Sequence No: 1, Text Type: N, H10
[59976921]
On october 13th 2016 copan (b)(4) received an email from its distributor (b)(4) saying that in july 2016 they had received a complaint about an event dated (b)(6) 2016. In the communication received by the distributor, the user said that "nurse a informed loss tip of flocked swab ( ~5. 5 cm) over lt nostril after the procedure was performed with patient a. " the event happened in (b)(6). We received the sample and it is clear that the breakage occurred at the first diameter change from the tip. The 17th of october our customer care sent a questionnaire to the distributor asking for more information about the event. The 7th of november we received an email from the distributor saying that the user refused to fill in the questionnaire, so we could not receive further details about the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005477219-2016-00007 |
| MDR Report Key | 6105213 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-11-16 |
| Date of Report | 2016-11-16 |
| Date of Event | 2016-03-13 |
| Date Mfgr Received | 2016-10-13 |
| Device Manufacturer Date | 2015-04-24 |
| Date Added to Maude | 2016-11-16 |
| 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 | 9030268721 |
| 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 | 2016-11-16 |
| Returned To Mfg | 2016-10-25 |
| Model Number | 503CS01 |
| Catalog Number | 503CS01 |
| Lot Number | YUDC00 |
| Device Expiration Date | 2018-04-30 |
| Operator | NURSE |
| Device Availability | R |
| 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 | 2016-11-16 |