The reported issue is confirmed on (b)(6) 2019.On (b)(6) 2019, the distributor received the affected administration set and confirmed that it arrived with the pinch clamp facing the wrong direction.The distributor mentioned that the pinch clamp had been cut in two places.The distributor inquired the initial reporter how the cuts in the pinch clamp could had come about.The initial reporter responded that it was because the nurses were trying to take off the pinch clamp in order to reinstall it right side up.The contract manufacturer inspected their manufacturing process, and the root cause of the reported issue is training deficiency of manufacturing line personnel.The addition of new personnel to the manufacturing lines and the current product manufacturing layout opportunities of improvement are two major contributors to this situation.Opportunities to improve the process were identified that the line layouts would be updated in order to modify the assembly sequence.The manufacturing personnel at the becton, dickinson and company would also be trained with the new layout update.On (b)(6) 2019, this issue has been added to scar 2019-002, which was initially opened and sent to the contract manufacturer becton, dickinson and company on (b)(6) 2019.
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