MAUDE Adverse Event Report: COPAN ITALIA SPA FLOQSWABS

Model Number A321CS02

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 03/27/2020

Event Type  malfunction  

Manufacturer Narrative

Since no confirmation on the kit lot was received, the internal investigation was carried out considering the two kit lots (#200313300 and #200577300) of model # 321c containing the swabs lot #2003060 model# a321cs02 and sold to the hospital "(b)(6)" that is supposed to be the complainant based on the lot traceability.For each referred lot the following analysis have been performed: - documental review: bhr 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: documentation related to sterilization process has been examined and no anomalies linked to the reported issue have been detected.- retains inspections: the visual inspection and the mechanical tests performed on copan's retains considering both swabs included into a321cs02 didn't show anomalies: the sticks appeared intact and resistant; no breakages signals have been found.The analysis of historical data didn't show other complaints of the same type associated to the lots #200313300 and #200577300 which were sold to several customers.Considering the bhr review and the tests performed on retains, the internal investigation could not confirm any malfunction or defect in the device lots associated with this incident.An analysis of the incidence of the problem (swab breakage during collection) has been performed from 2016 up to date taking into consideration both swab geometries.Considering the complaints received and the volume of pieces sold worldwide for all the product codes having the same swab geometry, the failure incidence is 1.5 in 10 million for pernasal swab and 0 for regular swab.Considering that to our knowledge no event has led to serious medical consequences so far in similar circumstances (breakage of the swab during collection), that the failure rate for both swab geometries is very low, that the swab breakage has been already evaluated in the risk analysis of the product, 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 from the customer.

Event Description

The event occured in canada.On (b)(6) 2020 copan received a report from the (b)(6) describing the following event "used small floq swab from vtm package lot#2003060 (swab) for covid test.Passed in nostril first than to right nostril, kinked, redirected and passed.When pulled swab stick out stick broken.Piece left in nose.Pt did not choke or move while doing test.Floqswab stick small size lot#2003060 in utm package from copan.Consequence " vs stable, no coughing, calm needed or for removal of piece thought to be left in bronchus".The claimed model # was ca349c.This model # does not correspond to a copan model#.Based on the lot traceability (the provided lot# 2003060 was referred to the swab in the utm kit), the correct model# should be 321c.Copan made 3 attempts contacting the email address reported in the form received from (b)(6) (on 24th apr, 29th apr and 5th may) asking for a confirmation of model# and sending a questionnaire to further investigate the incident.No response has been received from the customer.

• Brand Name: FLOQSWABS
• Type of Device: FLOQSWABS
• Manufacturer (Section D): COPAN ITALIA SPA; via f. perotti 10; brescia, italy 25125 ; IT 25125
• Manufacturer (Section G): COPAN ITALIA SPA; via f. perotti 10; brescia, italy 25125 ; IT 25125
• Manufacturer Contact: stefania triva ; via f. perotti 10; brescia, italy 25125 ; IT 25125
• MDR Report Key: 10078137
• MDR Text Key: 192263621
• Report Number: 3002444944-2020-00001
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/28/2022
• Device Model Number: A321CS02
• Device Catalogue Number: A321CS02
• Device Lot Number: 2003060
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention