MAUDE Adverse Event Report: COPAN FLOCK TECHNOLOGIES SRL FLOQSWAB; APPLICATOR, ABORBENT TIPPED, STERILE, PRODUCT CODE: KXG

Model Number 503CS01

Device Problems Break (1069); Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 04/12/2019

Event Type  malfunction  

Manufacturer Narrative

Copan checked the device history records related to the manufacturing and controls before the release on the market of the reported product 503cs01, lot number 1812449 ( (b)(4) pieces).No anomalies have been found.No other incidents on the same lot have been reported.The involved device was not available to be returned to copan for evaluation.Mechanical swab shaft bending tests (according to release sop) have been performed on the retained samples of the reported lot on the point where the breakage occured, in order to test shaft resistance to breakage.All the swabs subjected to the bending tests gave conforming results.Following the receipt of the filled questionnaire, additional clarifications/information have been requested.The internal investigation is still in progress.A follow-up report will be sent.

Event Description

The event occurred in (b)(6).On (b)(6) 2019 copan received an email from its (b)(4) distributor informing that: " the end-user reports that a swab broke at the breaking point in the baby's nasal (a (b)(6) baby) while a nurse was getting some nose sample.The nurse tried to remove the broken part by suction but failed.Two times of ct scannings failed to find the broken part, either.Yesterday, 7 days later, it was found from the baby's excrement".On the same day, copan sent a questionnaire to the distributor in order to acquire more information on patient's health and on the event for the internal investigation.On (b)(6) 2019 copan received the questionnaire completed with information provided by a specialist present at the time of the event.The following details have been reported: the swab was used for a nasopharyngeal collection to detect influenza infection.The sample collection was performed as described in the ifu of standard q influenza a/b test (diagnostic kit sd biosensor, inc.).No pre-collection steps were performed.The patient was sedated and collaborative during the sampling.No sign of damage was visible on the swab before the use.The swab broke at the first diameter change.Following this event, on (b)(6) 2019, patient was inspected using ct and x rays and since no pieces were found, on the same day an additional ct was performed in a different hospital.No piece was found.The broken piece was discarded by feces on (b)(6) 2019.No serious injury on patient was notified.The specialist confirmed that the patient was restored.

Manufacturer Narrative

The internal investigation reported with the initial mdr is confirmed.In addition, copan investigated this incident considering the information received for the 3 events to determine if a root cause was attributable to the use of the swab as a component of the sd biosensor's kit.Copan checked the content of the ifu of standard q influenza a/b kit that include instructions for nasopharyngeal collection using the swab.The ifu's kit showed no misalignment with the content of copan's instructions for sample collection.A further evaluation was performed taking into consideration the packaging of standard q influenza a/b.The kit includes #25 pieces of swab #503cs01.The kit packaging (inclusion of copan swabs into standard q influenza a/b) is performed by the sd biosensor inc.Using an internal sd biosensor sop.This sop was not shared with copan so no consideration on the packaging process was possible.On july 3rd, 2019 copan received a sample of the sd biosensor's standard q influenza a/b kit for internal evaluation (the lot of the kit was not one of those involved in the incidents).The internal investigation could not identify a root cause related to the use of the swab #503cs01 with standard q influenza a/b; however, we cannot exclude that the reprocessing activities (packaging of the kit) performed by sd biosensor inc may have contributed to the incidents.An analysis of the incidence of the problem has been performed from 2014 up to date.Copan received 19 worldwide complaints related to breakage of swab during sampling collection procedure for product containing the same type of swab #503cs01.Comparing the number of these complaints with the number of pieces sold worldwide from 2014 to 2018: the failure incidence (floqswabs 503cs01 breakage during sampling) is 2,02 in 10 millions.Considering that it was not possible to establish a correlation between the use of the swab into sd biosensor kit and these incidents, that the swab breakage has been already considered as hazard in the product risk analysis, that to our knowledge no event has led to serious medical consequences so far in similar circumstances (breakage of the swab during collection) and that the incidence rate is very rare, no corrective actions is planned at this time.Copan will continue to monitor products for similar events.

Event Description

This is a follow-up report for a case of swab broken during specimen collection occurred in korea (initial report # 3005477219-2019-00002).In addition to the information provided with the initial report, copan received the confirmation that the picture provided with the filled questionnaire sent by the distributor on 14th may 2019 was related to the broken swab.Picture confirmed that the swab broken at the first diameter change.The picture does not provide any additional information useful for the internal investigation.This incident was the first of three incidents occurred in korea between (b)(6) 2019 and (b)(6) 2019 for a swab (product code #503cs01) broken during nasopharyngeal collection.Notification was received by the same korean distributor.Copan submitted an mdr report as manufacturer (# 3005477219-2019-00002, # 3005477219-2019-00003, # 3005477219-2019-00004) for each of these events.Copan found out that the involved swab #503cs01 (released on the market by copan as a single product) was a component of the kit standard q influenza a/b for the influenza virus a type and b type antigens detection made by sd biosensor inc.On 31st july, copan became aware that the sd biosensor's kit standard q influenza a/b is not sold on us market.

• Brand Name: FLOQSWAB
• Type of Device: APPLICATOR, ABORBENT TIPPED, STERILE, PRODUCT CODE: KXG
• Manufacturer (Section D): COPAN FLOCK TECHNOLOGIES SRL; via f. perotti 16-18; brescia, 25125 ; IT 25125
• MDR Report Key: 8619815
• MDR Text Key: 146487891
• Report Number: 3005477219-2019-00002
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2021
• Device Model Number: 503CS01
• Device Catalogue Number: 503CS01
• Device Lot Number: 1812449
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 MO