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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.Bd lot #180824252 (151,050 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 #180824252.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 didn't 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 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 (b)(6) 2020 copan received a report from the distributor beckton dickinson (on behalf of a final user) informing that "a swab entered right nostril and broke off at junction of slender shaft and thicker shaft handle" when using the product code 503cs01.Bd (bd ref.(b)(4), lot #180824252.The following information were also provided : per the collecting nurse, the patient did not struggle or move about during collection.In order to remove the swab end, the patient was taken to the operating room.According to the operative report, an endoscope was utilized.Due to the difficulty of removal and extreme discomfort, patient consented to sedation.It was noted no bleeding or coughing/signs of aspiration were seen".On (b)(6), copan diagnostics (copan (b)(4) us agent), received a report (mw5095248) in the mailbox through the fda's medwatch program for the same event.The report was filled by the facility where the event occured.The report confirmed the initial information received and added the following details: the swab breakage occurred during specimen collection for sars-cov-2 ; due to the need for a procedure to remove the swab, a rapid molecular test was carried out to check sars-cov-2 positivity.On (b)(6), copan sent a questionaire to the facility for obtaining details on the event and patient's condition.On (b)(6), the filled questionnaire was received by copan with the following additional information: the sampling collection was carried out according to the cdc guidelines available on the website (insertion of the minitip swab through the nostril parallel to the palate, not upwards); the swab was used as is, no pre-collection steps were performed on it; the swab was passed into the nostril once; no obstacles were identified during the insertion of the swab in the nostril which was easy and smooth; the breakage occured at the first diameter change from the tip of the swab.To remove the swab, the patient was sedated and the swab removed using a rigid endoscopy with a 0° blackestey forceps.The swab piece was found.The involved patient was recovered and no apparent complications were noticed: the oxygenation rate was within expected value, as well as pulse, blood pressure, temperature and pain control.The patient was adequately hydrated and no vomiting was observed.
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