MAUDE Adverse Event Report: COPAN ITALIA SPA FLOQSWABS

Model Number 518CS01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 04/23/2020

Event Type  malfunction  

Manufacturer Narrative

The following internal investigation was performed on catalogue # 518cs01, lot # 1908291 ((b)(4) pieces): 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.No anomalies linked to the reported issue have been detected.Historical data analysis: two complaints of the same type (swab breakege during collection) were recorded on the lot #1908291.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.No specific root cause for the swab breakage during patient collection has been 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, the failure incidence is 7,8 in 10 million.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.

Event Description

On 03rd august 2020, copan received an e-mail from (b)(6) informing that "(b)(6) 2020, 11:00am.(b)(6).Patient being tested for covid19.Respiratory therapist, unit director, and bedside rn at bedside to help.Patient swabbed without moving, and part of swab broke off inside patients nostril.Attempts to retrieve the swab were unsuccessful.Dr called, and ent was consulted.Ent came to bedside to scope patient.2mg versed given for sedation to scope patient.Scope successful but unable to locate swab.Chest xray ordered to confirm if swab is in patients lung.Patients vital signs stable, in no distress, and on room air sats in mid 90s.Thoracic consulted.Pt refused bronchoscopy.No c/o of shortness of breath." on 05th august 2020, copan contacted (b)(6) to retrieve more information on the incident, and to confirm the product code and lot # involved.The product code involved was the copan catalogue # 518cs01, lot 1908291.On 13th august, copan 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 28th august, copan received the form filled in.The report confirmed the intial information recevied, and added the following details: pt swabbed without moving and tip of swab broke; no pre-collection steps were performed on the swab; the patient was calm; nothing visually was seen in nose; the insertion of the swab into the nostril was easy; the swab was passed into the nostril once;the swab was inserted into nare, spinned around to collect specimen, pulled out swab, tip missing.No information on the point where the breakage occured was available.Fiberoptic nasal endoscopy/laryngoscopy, versed 2mg given was done to removed the swab: no foreign bodies were visualized in the nasal cavity, the nasopharynx, or the larynx.

• 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: 10498897
• MDR Text Key: 206149414
• Report Number: 3002444944-2020-00009
• 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: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2022
• Device Model Number: 518CS01
• Device Catalogue Number: 518CS01
• Device Lot Number: 1908291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/03/2020
• Event Location: Other
• Date Manufacturer Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 100