Foreign: report source: (b)(6).Manufacturing date: device released for distribution on date provided per review of the dhr.Device evaluation: one portex device was returned for investigation.The device had residue present throughout the aspiration tubing, under the balloon cuff, and it was noticed that the suction control connector component was missing.A leak test was performed on both the aspiration and balloon cuff airway lines to determine if a leak existed in either airway and leaks were present in both airways.Two holes were present in the red plug and visible when the plug was stretched length-wise.One hole was present on the aspiration airway tubing, and the tubing appeared to be pinched where the hole was located.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.Devices are 100% inspected for leaks by manufacturing and a sample of each lot is leak tested by quality.Based on the investigation, the complaint allegation was confirmed.However, the investigation determined that the device did meet manufacturing specification when released for distribution and there was no manufacturing defect identified.The event problem source is listed as unknown.
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