NOVOSYN UNDYED 2/0 (3) 70CM DS24 (M)RCP

Description of Event or Problem

It was reported an issue with Novosyn suture.The client reported that the patient presented with bleeding from the wound. Upon assessment, wound dehiscence, warmth, and redness were observed.No further information has been received.

Additional Manufacturer Narrative

Summary of investigation:There are no previous complaints of this code-batch of which wemanufactured and distributed in the market 12,096 units. There are nounits in our stock. We have received 4 cases of the same code-batch, 2cases regarding the same issue (thread slow degradation), and 2 casesregarding another issue (wound dehiscence and/or redness, bleeding).We have not received any sample for analysis.Without closed and/or defective samples a proper analysis cannot be carried out.According to the Side Effects of the Instructions for use (IFU) of the product: 'The following side effects may be associated with the use of this product: pain, granuloma, seroma, hematoma, rejection, enhanced bacterial infectivity, wound dehiscence, anastomotic leak and haemorrhage'.Batch Manufacturing Record:Reviewed the batch manufacturing record, this product had a normalprocess and the results during the process fulfil USP/EP and B.BraunSurgical requirements.Conclusion Root Cause Analysis:It has not been possible to determine the root cause because no samples have been received.Final conclusion:Without samples we are not in position to study 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.Corrective measures:Actions on distributed product 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.