The actual sample has been received for evaluation.Visual inspection revealed that the sterile was unopened and there was an area where plastic material had been damaged; stretched.Magnifying inspection found that the stretched area of the sterile bag was where the water port of the oxygenator had been located.In addition, the water port had been deformed.Magnifying inspection of the stretched area revealed that it had been stretched from the inside of the sterile bag.The thickness of the sterile bag material was measured and confirmed to be equivalent to that of a manufacturer retention sample.A review of the device history record and the product release judgement record of the involved product code/lot number combination revealed no findings.Ifu states: do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that since the unit box was deformed, it is likely that an excessive load was applied while the actual sample was in the unit box, causing a hole at the point where the reservoir was in contact with the sterile bag.It is likely to be due to handling during storage period why the actual sample was subjected to such an excessive load.However, the exact cause of the reported event cannot be definitively determined based on the available information.
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