Analysis and results: there are no previous complaints of this code batch.(b)(4).We have received an open and used sample with the needle detached from the thread, thread is not wound on the pack.Checking the thread end and needle attachment it can be seen that the needle is damaged in the attachment area and thread is broken.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.As indicated in the instructions for use of the product: precautions: always grasp the needle in a section 1/3 to ½ of the distance from the fiber attachment end to the needle point, never at the end where the fibre is attached or the needle point.Grasping the needle at the area of its point could impair the penetration performance and cause a fracture of the needle.Grasping the needle close to the fibre attachment end could cause bending, breakage.Final conclusion: in spite of receiving a defective sample, without closed samples a suitable analysis cannot be performed.Nevertheless, we take note of this incidence and if any closed sample is received in the future, we will re-open the case and analyse it.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.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.
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