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 breakage 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 (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.
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On 03rd august 2020 copan received an e-mail from (b)(6) informing that "(b)(6) - (b)(6) 2020.2:30pm.(b)(6).Covid swab broke off in patient's nose.(no other information documented)".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 out and the information "zp occurred (b)(6) 2020 in msicu" and "swab tip was retrieved at the bedside; no additional health care services were required".The report confirmed the initial information received and added the following details: entered nare, twirled around, when pulled back out flexible tip was gone; no information on the point where the breakage occured was available.No pre-collection steps were performed on the swab; airways was checked before collection by visual observance; the insertion of swab was very easy; the swab was passed into the nostril once; a nasopharyngeal endoscopy procedure was performed, and the swab was identified below the inferior turbinate and retrieved.
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