A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Udi section is unknown, no product information has been provided to date.Date of event is unknown, no information has been provided to date.
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One used device was received for investigation.The reported issue was confirmed during visual inspection, which identified a rupture in the proximal end of the airway balloon, near the connector.No product lot number was provided, therefore, no review of manufacturing device history records could be conducted.Based on the available information, the investigation confirmed the reported complaint.The observed rupture was determined to be consistent with damage caused by improper handling of the device balloon, however the investigation could not identify a definite root-cause.A notification of this complaint's details was provided to production personnel and complaint trends will be monitored with actions taken as needed.The customer was provided with a copy of the cautions for handling section of the device instructions for use.
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