MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-27 for FLOQSWAB 503CS01 manufactured by Copan Flock Technologies Srl.
[146489029]
Copan checked the device history records related to the manufacturing and controls before the release on the market of the reported product 503cs01, lot number 1816965 ( (b)(4) pieces). No anomalies have been found. No other incidents on the same lot have been reported. The involved device was not available to be 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 the point where the breakage occured, in order to test shaft resistance to breakage. All the swabs subjected to the bending tests gave conforming results. Following the receipt of the filled questionnaire, additional clarifications/information have been requested. The internal investigation is still in progress. A follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
[146489030]
The event occurred in (b)(6). On (b)(6) 2019 copan became aware that a swab broke during a sample collection. The information was received by email from a (b)(4) distributor. The email stated that the broken part of the swab was removed with endoscope. On (b)(6) 2019, copan sent a questionnaire to the distributor in order to acquire more information on patient's health and on the event for the internal investigation. On (b)(6) 2019 copan received the questionnaire completed with information provided by the manager of diagnostic test department. The following details have been reported: the swab was used for a nasopharyngeal collection to detect influenza infection. No pre-collection steps were performed. The patient was sedated and collaborative during the sampling. No sign of damage was visible on the swab before the use. The swab broke at the first diameter change. Since the broken part was not immediately found, on the same day of the event, additional tests were performed at otorhinolaryngology hospital and a ct and endoscopy were performed. The broken piece was discharged by feces the day after the incident, not removed by endoscope as initially informed. Since the patient felt emotional anxiety, he needed psychotherapy treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005477219-2019-00003 |
| MDR Report Key | 8644180 |
| Date Received | 2019-05-27 |
| Date of Report | 2019-04-29 |
| Date of Event | 2019-04-22 |
| Date Mfgr Received | 2019-04-29 |
| Date Added to Maude | 2019-05-27 |
| 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 G1 | COPAN FLOCK TECHNOLOGIES SRL |
| Manufacturer Street | VIA F. PEROTTI 16-18 |
| Manufacturer City | BRESCIA, |
| Manufacturer Country | IT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FLOQSWAB |
| Generic Name | APPLICATOR, ABORBENT TIPPED, STERILE, PRODUCT CODE: KXG |
| Product Code | KXG |
| Date Received | 2019-05-27 |
| Model Number | 503CS01 |
| Catalog Number | 503CS01 |
| Lot Number | 1812449 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COPAN FLOCK TECHNOLOGIES SRL |
| Manufacturer Address | VIA F. PEROTTI 16-18 BRESCIA, 25125 IT 25125 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-27 |