It was reported an issue with dafilon suture.The client reported that suture threads usp 3/0 and 4/0, sent as a replacement for other threads previously in use, are by no means ideal substitutes as they have needles that do not pierce the skin unless using incorrect force and methodical not correct.The threads are not superimposable in terms of quality, memory, smoothness to the corresponding ones from other companies.The thickness also does not match the 3/0 and 4/0 sizes.Related file: 400602563_3003639970-2023-00184.Additional information has been requested.
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After having reviewed customer documents, we found that the possible article codes involved are (b)(4).The first article code (c0916134) was inserted by mistake.Two possible codes involved: (b)(4)- dafilon blue 4/0 (1.5) 45cm dsmp13 (m).(b)(4)- dafilon blue 4/0 (1.5) 45cm dsmp19 (m).Analysis and results: the involved batch is not known.As no batch number is available, the batch manufacturing record and the complaint history record cannot be reviewed.We have not received any sample for analysis.Without any closed and/or defective sample we cannot carry out an analysis in order to take a decision.Remarks: care should be taken to avoid damaging the needle when using the suture material.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.Reshaping needles should be avoided and may result in a loss of their strength and resistance towards bending and breaking.Final conclusion: without samples or more information we are not in position of studying if the affected product does not fulfil the specifications.In consequence, a proper analysis cannot be done, and the case is not confirmed due to lack of evidence.Nevertheless, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyse it.Please note that when no samples are received our analysis is very limited.We regret any inconvenience this issue may have caused and thank you for your collaboration.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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