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

Model Number 503CS01.SX

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

The swab 503cs01.Sx was a component of the kit starswab multitrans system product code s160-naso lot 0f03b manufactured by pretium canada packaging ulc.The kit is used for the collection and transport of viruses, chlamydiae, mycoplasmas and ureaplasmas obtained from clinical specimens.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.Sx lot # 2007471 (150050 pieces).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 # 2007471; 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 sop.The tests did not show anomalies: the sticks appeared intact and resistant; no breakages signals have been found.Copan checked the package insert provided by starplex for the collection kit "starswab multitrans system product code s160-naso" and the link to the copan collection guide provided by the health unit where incident occured to verify the content related to the swab instructions.No significant elements were identified.The internal investigation could not confirm any product defect in the device lot associated with this incident, and 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 1.58 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 2nd sept, copan became aware of a swab applicator that broke during use.The incident occured at (b)(6).The following information from the client (b)(6) were received: "the swab applicator (503cs01.Sx lot 2007471) was packaged with starswab multitrans system product code s160-naso lot 0f03b.The end user supplied photos of the broken swab and the following statement: "swab broke when it was in the patients nose and she had to attend the er to have it removed.Approximately 2 inches of swab was removed from the patient.There was nothing abnormal about the collection and the rn has done hundreds of these swabs." on 22th sept, copan received the following relevant additional information in a form completed by the lab technologist in contact with the registered nurse: the swab broke at the first diameter change from the tip during a nasopharyngeal sampling for covid-19; the instructions for use of a similar kit produced by copan were followed: the swab was gently inserted until resistance was felt, and then the swab was rotated for about 5 seconds.The patient was collaborative, and the insertion was easy.The airways were not checked before the sampling, and it was unknown if a pre-collection step was performed.The patient was full recovered.

• Brand Name: 503CS01.SX
• 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, lombardia 25125 ; IT 25125
• Manufacturer Contact: stefania triva ; via f. perotti 10; brescia, italy 25125 ; IT 25125
• MDR Report Key: 10605515
• MDR Text Key: 209211038
• Report Number: 3002444944-2020-00011
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2023
• Device Model Number: 503CS01.SX
• Device Lot Number: 2007471
• Date Manufacturer Received: 09/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR