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U.S. Department of Health and Human Services

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

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COPAN FLOCK TECHNOLOGIES SRL (PREVIOUSLY MICRORHEOLOGICS SRL) COPAN SWAB Back to Search Results
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.
 
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Brand NameCOPAN 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 Key2794675
MDR Text Key10379455
Report Number3005477219-2012-00001
Device Sequence Number1
Product Code KXF
Combination Product (y/n)N
Number of Events Reported1
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 Received10/15/2012
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2012
Device Model Number516CS01NT
Device Catalogue Number516CS01NT
Device Lot NumberMRLA00
Was Device Available for Evaluation? No
Date Manufacturer Received03/07/2011
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2009
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
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