MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-06-09 for FLOQSWAB 503CS01 manufactured by Copan Flock Technologies.
[46893027]
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 503cs01, lot number y7fq00 (121000 pieces). No anomalies have been found. This is the first event received on this lot. The involved device was not returned to copan for evaluation. Mechanical swab shaft bending tests 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. (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
[46893028]
On (b)(6) 2016 copan received an email from its distributor saying that they received a notification from (b)(6) hospital were a product broke during sampling and that the patient was sent to the ear nose and throat emergency room to remove the tip of the swab. On (b)(6) 2016 copan sent a questionnaire to the distributor in order to acquire more information. On (b)(6) 2016 copan received the questionnaire filled in. According to information received a nasopharyngeal sampling was taken from a male patient, aged (b)(6), with a flocked swab, code 503cs01. Patient was sedated during collection. During sampling the swab broke at the first diameter change and the broken piece remained in patient's nasal cavity. An otorhinolaryngologist intervened in order to retrieve the broken piece of the swab; after recovery the piece was wasted. Patient was not awake during the all process and no injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005477219-2016-00005 |
| MDR Report Key | 5709046 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-06-09 |
| Date of Report | 2016-06-09 |
| Date of Event | 2016-04-24 |
| Date Mfgr Received | 2016-05-12 |
| Device Manufacturer Date | 2015-02-12 |
| Date Added to Maude | 2016-06-09 |
| 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 | 2016-06-09 |
| Model Number | 503CS01 |
| Catalog Number | 503CS01 |
| Lot Number | Y7FQ00 |
| Device Expiration Date | 2018-01-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-06-09 |