The customer reported that after several attempts to place a nasogastric salem sump without success, it was noticed that the tube was not patent and in fact had no holes in the end of it.Per additional information received on 01jun2022, the device was replaced.There was no medical intervention given.
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The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on october 28, 2021.One sample with lot number 2129900664 was received for the investigation.A visual inspection was performed, and missing eyes (holes) were observed.The current process and controls were reviewed and found properly followed, including sub-assemblies, finished product assembly, packaging, and inspections performed to the product.There were no abnormal conditions found that could trigger the reported condition.Based on the investigation performed, a possible root cause was detected, it is possible that missing eyes could occur if brackets from the pouching machine are worn.In addition, an improvement opportunity was detected in the standard work instructions.To address the reported condition, maintenance was created for the brackets of the pouching machine and the work instructions were modified to include a 100% visual inspection by personnel production to verify that catheter has poached eyes.This complaint will be used for tracking and trending purposes.
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