Samples received: 1 unopened pouch.Analysis and results: there are no previous complaints of this code batch.There are no units in stock b.Braun surgical's warehouse.We have received a closed unit with leakage in the pack.The sample received is empty of liquid.Leakage is caused by a defect in the sealing step which is not detected in the process, only after a time when the solution makes contact with the affected part of the aluminum and caused deterioration of it.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Please note that the product must be stored under 25ºc as indicated in the product label.Final conclusion: taking into account that the results of samples received do not fulfil the b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the samples received.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.
|