MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-21 for FLOQSWAB 503CS01 manufactured by Copan Flock Technologies Srl.
[36917165]
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 tvp400 ((b)(4)). 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. 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 floqswab 503cs01. All the (b)(4) events were reported to fda as mdrs. (b)(4). Considering that the internal investigation could not confirm any malfunctions/defects in the device lot associated with this incident, that the patient's condition was critical (life support needed) before the swab collection and that continued to deteriorate since did not respond to multiple pressors (levophed, epi and vasopressor; also unable to tolerate crrt), 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 failure rate is very rare, no further action is planned at this time. Copan will continue to monitor products for similar events.
Patient Sequence No: 1, Text Type: N, H10
[36917167]
A report was sent by the initial reporter to fda ((b)(4)). Copan diagnostics as copan flock technologies us agent became aware of the event on (b)(4) 2015. The medwatch from fda was received in the mailbox as first and sole notification of the event. The description of the event in the report submitted by the user was as follows: "rn was doing a nasopharyngeal swab for flu/respiratory virus panel that md had ordered. Upon removing the nasopharyngeal swab from nose, the nurse saw that the swab had broken off with approximately two inches missing off the end. Md was notified and attempted to remove without success. The plan was then consult ent team however, patient's condition continued to deteriorate and family decided to remove patient from life support. The patient died the following day. What was the original intended procedure? To obtain a nasopharyngeal swab sample. This was the first time that we are aware of this type of incident with this product. Device usage problem: device failed (e. G. Broke, couldn't get it to work or stopped working)". On 01/12/2016 copan contacted (b)(6) (initial reporter and risk manager of the hospital) by phone call; she confirmed that the patient died for reasons different from the breakage of the swab and that no report was sent to the product manufacturer. In the same date copan sent to (b)(6) a questionnaire for further investigate the event. On 01/13/2016 copan received the completed questionnaire from (b)(6) that included further information on the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005477219-2016-00001 |
| MDR Report Key | 5383206 |
| Date Received | 2016-01-21 |
| Date of Report | 2016-01-21 |
| Date of Event | 2015-12-10 |
| Date Facility Aware | 2015-12-31 |
| Report Date | 2016-01-21 |
| Date Reported to FDA | 2016-01-21 |
| Date Reported to Mfgr | 2015-12-31 |
| Date Mfgr Received | 2015-12-31 |
| Device Manufacturer Date | 2014-12-30 |
| Date Added to Maude | 2016-01-21 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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, LOMBARDIA 25125 |
| Manufacturer Country | IT |
| Manufacturer Postal | 25125 |
| Manufacturer Phone | 9030268721 |
| Manufacturer G1 | COPAN FLOCK TECHNOLOGIES SRL |
| Manufacturer Street | VIA F. PEROTTI 16-18 |
| Manufacturer City | BRESCIA, BRESCIA 25125 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 25125 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FLOQSWAB |
| Generic Name | APPLICATOR, ABSORBENT TIP, STERILE |
| Product Code | KXG |
| Date Received | 2016-01-21 |
| Model Number | 503CS01 |
| Catalog Number | 503CS01 |
| Lot Number | TVP400 |
| Device Expiration Date | 2017-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| 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, LOMBARDIA 25125 IT 25125 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-01-21 |