MAUDE Adverse Event Report: COPAN FLOCK TECHNOLOGIES SRL (PREVIOUSLY MICRORHEOLOGICS SRL) COPAN SWAB

Model Number 516CS01NT

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/02/2011

Event Type  Injury  

Manufacturer Narrative

Manufacturer investigation report: our original complaint investigation could not confirm any malfunction or defect in the device lot associated with this incident. The dhr was reviewed and no anomalies have been found during all the production steps of the different product components. (b)(4). The test performed on the retained sample from the claimed lot was done following internal sop for mechanical resistance test. All the tested swabs gave results within the acceptability limits. (note: the samples tested were coming from the same large lot number but not the same batch number). (b)(4). As a results of fda inspection, copan (b)(4) has reviewed its criteria for a reportable event and has reviewed complaints from 2011 and 2012 to identify reportable events under the reviewed reporting criteria.

Event Description

The event occur in (b)(6). The description is provided by local distributor as it was reported to him by the user. During a collection of a naso-pharyngial specimen the flocked swab contained in the clearview influenza a/b kit, broken when it was used onto pt approximately at 4-5 cm from tip end. The broken swab head remained in pt nose. Immediately, the doctor look for it by endoscope, but it was not found. The pt refused additional examination, and he went back home. The incident date was (b)(6) 2011, and no issue on him has reported until now, so we may guess that it was eliminated.

• Brand Name: COPAN SWAB
• Manufacturer (Section D): COPAN FLOCK TECHNOLOGIES SRL (PREVIOUSLY MICRORHEOLOGICS SRL); via f. perotti 16-18; brescia 2512 5; IT 25125
• Manufacturer Contact: via f. perotti 16-18; brescia 25125 ; 302687211
• MDR Report Key: 2794675
• MDR Text Key: 10379455
• Report Number: 3005477219-2012-00001
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Type of Report: Initial
• Report Date: 03/07/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2012
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/31/2012
• Device Model Number: 516CS01NT
• Device Catalogue Number: 516CS01NT
• Device Lot Number: MRLA00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/15/2012 Patient Sequence Number: 1