MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-06-18 for COPAN VENTURI TRANSYSTEM 108C.USE manufactured by Copan Italia S.p.a..
[21109670]
The event occured in j(b)(6). A swab without fiber tip was used to collect a sample from the vagina of a patient. After procedure, the doctor noticed bleeding and patient injury.
Patient Sequence No: 1, Text Type: D, B5
[21160668]
Manufacturer investigation report: the dhr was reviewed and no anomalies have been found during all the production steps of the different product components. Device problem was due to the breakage of the swab being sealed between two packages. This defect is visible by users. It is stated on the product package insert to discard product that is damaged. Visual test was performed on the retained samples from claimed lot. Our investigation could not confirm any other malfunction or defect in the device lot associated with this incident. No other complaints were recorded on the device lot associated with this incident. Evaluation of the device that caused the incident was performed on photographs provided by the user. (note: the samples tested were coming from the same large lot number but not the same batch number).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002444944-2013-00001 |
| MDR Report Key | 3199240 |
| Report Source | 08 |
| Date Received | 2013-06-18 |
| Date of Report | 2013-04-29 |
| Date of Event | 2013-04-27 |
| Date Mfgr Received | 2013-04-29 |
| Device Manufacturer Date | 2011-11-01 |
| Date Added to Maude | 2013-07-02 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | VIA F. PEROTTI 10 |
| Manufacturer City | BRESCIA 25125 |
| Manufacturer Country | IT |
| Manufacturer Postal | 25125 |
| Manufacturer Phone | 302687212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COPAN VENTURI TRANSYSTEM |
| Product Code | JSL |
| Date Received | 2013-06-18 |
| Model Number | 108C.USE |
| Catalog Number | 108C.USE |
| Lot Number | E9SV00 |
| ID Number | 003N45 |
| Device Expiration Date | 2014-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COPAN ITALIA S.P.A. |
| Manufacturer Address | VIA F. PEROTTI 10 BRESCIA 25125 IT 25125 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-06-18 |