MAUDE Adverse Event Report: COPAN ITALIA SPA FLOQSWABS

Model Number XA5S108B01

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 05/09/2020

Event Type  malfunction  

Manufacturer Narrative

For the lot # 1919615 of model # xa5s108b01 the following analysis have been performed: sterilization process review: the documentation related to the sterilization process has been examined and no anomalies linked to the reported issue have been detected; retains inspections: the visual inspection and the mechanical verification were performed on copan's retains according to the internal operative procedure.The tests didn't show anomalies: the sticks appeared intact and resistant ad no breakages signals have been found; since catalogue # xa5s108b01 lot # 1919615 was included in lots # 200129600 and 200184400 of cepheid's kit catalogue # swab/b-100, the batch history record of both kit lots were reviewed and no deviations/annotations linked to the reported issue have been detected.The analysis of historical data didn't show other complaints of the same type associated to the lot # 1919615.Considering the bhr review and the tests performed on retains, the internal investigation could not confirm any malfunction or defect in the device lot associated with this incident.An analysis of the incidence of the problem (swab breakage during collection) has been performed from 2018 up to june 2020.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 (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), that the failure rate 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

A report was sent by the initial reporter to fda through fda's medwatch program (report #mw5094632).Copan diagnostics as copan (b)(4) us agent became aware of the event on 06/02/2020.The report was received in copan diagnostics' mailbox as first and sole notification of the event.The event has been described as follow: "copan floqswabs, during an attempt to collect a culture on a patient for covid-19, the tip of the pcr swab that was used (about 4.5cm) broke off and it got stuck in the nasopharyngeal cavity".The claimed catalogue # was xa5s108b01 lot # 1919615.This item is part of a collection kit of cepheid.The kit's product code is: swab/b-100 and it's manufactured by copan for cepheid.On june 05th, 2020 copan contacted by email ms.(b)(6) (initial reporter) ; she informed that the event occured in (b)(6) medical center and sent a photo of swab pouch confirmed the lot involved.On june 11th, 2020 copan sent a questionaire to further investigate the incident.Since no answer were received, 4 additional attempts were made (on june 17th, june 24th and june 29th, 2020 by email and a phone call on june 29th, 2020 leaving a message on the voicemail).No additional information was received by copan from the initial reporter till now.

• 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: 10218722
• MDR Text Key: 223807100
• Report Number: 3002444944-2020-00005
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2023
• Device Model Number: XA5S108B01
• Device Catalogue Number: XA5S108B01
• Device Lot Number: 1919615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/02/2020
• Event Location: Other
• Date Report to Manufacturer: 06/02/2020
• Date Manufacturer Received: 06/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1