MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-02-13 for FLOQSWAB 503CS01 manufactured by Copan Flock Technologies Srl.
[139060294]
Since no reference to the involved lot number was provided by the customer, copan performed an internal investigation considering all lots of cod. 503cs01 sold to the distributor from the beginning of the relationship between parties (lots reference: 1807592 - 1814374 - 1814372 - 1809095 - 1814373 - 1821362). For each lot referred above the following analysis have been performed: documental review: batch history record has been examined and no deviation have been found, neither during the moulding of the sticks, nor during the flocking/packaging processes and the final verification for the lot release. Sterilization process review: all documentation related to the ethylene oxide sterilization process has been examined and no anomalies linked to the reported issue have been detected. Retains inspections: the visual inspection and the fragility test performed on copan's retains according to the internal operative procedure didn't show anomalies: the sticks appeared intact and resistant, no breakages signals have been found. An analysis of the incidence of the problem has been performed from 2014 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 2014 to 2018, the failure incidence (breakage during sampling) is (b)(4). Considering 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 low, no further action is planned at this time. Copan will continue to monitor products for similar events and will reopen the assessment of this complaint if additional information will be received.
Patient Sequence No: 1, Text Type: N, H10
[139060295]
The event occurred in (b)(6). On 6th jan 2019 copan received an email from its (b)(4) distributor informing that a swab was broken and swallowed during sampling in the hospital and that they did not find it on the x-ray test. No information about the lot number was provided. On 08th jan 2019 copan contacted the distributor asking details on the lot number. On 09th jan 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. No information was received from distributor. Further to the first attempt, copan made 4 additional attempts to request further information by email (on the 14th jan 2019, 24th jan 2019 and 25th jan 2019, 1st feb 2019). Since no useful information was provided, a last attempt was done by phone on 04th feb 2019. No one answered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005477219-2019-00001 |
| MDR Report Key | 8335169 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-02-13 |
| Date of Report | 2019-01-06 |
| Date of Event | 2018-12-26 |
| Date Mfgr Received | 2019-02-11 |
| Date Added to Maude | 2019-02-13 |
| 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, ITALY |
| Manufacturer Country | IT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOQSWAB |
| Generic Name | APPLICATOR, ABORBENT TIPPED, STERILE, PRODUCT CODE: KXG |
| Product Code | KXG |
| Date Received | 2019-02-13 |
| Model Number | 503CS01 |
| Catalog Number | 503CS01 |
| 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, ITALY 25125 IT 25125 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-13 |