MAUDE Adverse Event Report: COPAN ITALIA SPA 503CS01; FLOQSWABS

Model Number 503CS01.DHI

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

From the information retrieved, it was found out that the item #503cs01.Dhi is part of the collection set ref 99-08015-vcf (diagnostic hybrids inc) provided along with a 3ml tube of transport media.The following internal investigation was performed: analysis of device history records: copan checked the internal records related to the manufacturing and controls before the release on the market of the reported product 503cs01.Dhi lot # 1915284 (b)(4).No anomalies linked to the reported issue have been detected.Historical data analysis: no other complaints of the same type were recorded on the lot #1915284; sterilization process review: copan checked the documentation related to sterilization process and no anomalies have been detected; retains inspections: visual inspection and mechanical tests were performed on copan's retains according to the internal operative procedure.The tests did not show anomalies: the sticks appeared intact and resistant; no breakages signals have been found.Copan checked the package insert of (b)(6) viral transport media and the links provided for the collection instructions to verify the content related to the swab instructions.No significant elements were identified.An analysis of the incidence of the problem (swab breakage during collection) has been performed from 2016 up to date.Considering the complaints received and the volume of pieces sold worldwide for all the product codes having the same swab type, (b)(4).Considering that the internal investigation could not confirm any product defect in the device lot associated with this incident, that no specific root cause for the swab breakage during patient collection has been identified , that the failure rate (swab breakage during collection) is very low and within the product risk analysis acceptability limit, the risk/benefit ratio is confirmed and 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

On 20th july 2020 copan received an e-mail from the customer (b)(6) informing that "we are currently still gathering information on the incident but it appears the swab broke at a point before the perforation inside the patient's nasal cavity.".On 20th july 2020, copan contacted (b)(6) to retrieve more information on the incident.On 21th july 2020, copan received other information by the customer: "the swab broke prior to the perforation inside the patient's nasal cavity when doing a collection for covid testing.They were unable to extract the swab in the nasal cavity.The emt was not able to locate the swab either so the patient went to the er where they performed a cat scan and no swab was found then either.This swab is included in our collection set made solely for (b)(6), ref 99-08015-vcf (our swab ref is 340-060)." the product code involved was the copan catalogue # 503cs01.Dhi, lot 1915284.On 27th july, copan contacted (b)(6) to retrieve more information on the incident and on the collection set.On 31th july, (b)(6) sent a copy of the package insert provided for the (b)(6) viral transport media.They do not provide specific instructions on collection but (b)(6) confirmed that (b)(6), provides specimen collection instructions for nasopharyngeal collection to their clients and they shared the web links for reference.On 3rd august, copan received pictures of the collection set from (b)(6) and sent to (b)(6) a form useful to acquire information and details about the event and patient conditions asking to submit it to the medical staff that performed the sample collection.On 7th august, copan made an attempt to receive the form sent filled in.No additional information was received till now.

Manufacturer Narrative

The internal investigation reported with the 30-days mdr is confirmed.There are no additional comments.

Event Description

This is a follow-up report for a case of swab broken during specimen collection.On 21th aug copan received back the pmdr questionaire filled with the following additional information: "provider was doing a covid swab and the swab broke off in the pt's nose.Provider went to retrieve with tweezers and then couldn't find swab.Clinic thinks pt accidentally swallowed it while trying to get it out of her nose; provider did everything correctly with regard to the collection procedure; the patient was collaborative, no sedated or intubated; the airways were checked before the collection; nostril insertion was easy.When provider went as far back as you should for a covid swab and that's when it broke.No resistance from within the nose; the swab was passed into the nostril one time; pt couldn't find the swab, went to er for a ct and they couldn't find it with imaging.This is why we think that pt accidentally swallowed while trying to get it out, with ears nose and throat all connected; as pt hasn't complained of anything else".The swab broke at the first diameter change from the tip.

• Brand Name: 503CS01
• Type of Device: FLOQSWABS
• Manufacturer (Section D): COPAN ITALIA SPA; via f. perotti 10; brescia, lombardia 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: 10419430
• MDR Text Key: 223812354
• Report Number: 3002444944-2020-00008
• 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: distributor,health profession
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2020,09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2022
• Device Model Number: 503CS01.DHI
• Device Catalogue Number: 340-060
• Device Lot Number: 1915284
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/20/2020
• Date Report to Manufacturer: 07/21/2020
• Date Manufacturer Received: 07/22/2020
• 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
• Patient Outcome(s): Required Intervention