MONOSYN VIOLET 5/0 (1) 70CM DS12 (M).RCP

Description of Event or Problem

It was reported an issue with Monosyn suture.The customer (veterinarian) reported that there is no needle in package. There is no patient involvement.

Additional Manufacturer Narrative

G4: Reported device not marketed in the U.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the U.S., K011375.Summary of investigation:There is a previous complaint of this code-batch regarding needle detachment closed as confirmed after analysis.We manufactured and distributed in the market (b)(4) units of this code-batch. There are no units in stock in B. Braun Surgical's warehouse.We have received one open and unused sample (without the aluminum pouch), the thread is still wound on the pack and the needle is missing.Although without any closed sample we cannot carry out an analysis in order to take a decision, taking into account the defective sample received and that there is a previous confirmed complaint of this code-batch regarding the same issue, we will consider this complaint as confirmed.Batch Manufacturing Record:Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil USP/EP and B. Braun Surgical specifications.Needle attachment strength results conducted on samples before releasing the product were 0.59 kgf in average and 0.44 kgf in minimum and fulfilled the requirements of the European Pharmacopoeia (EP): 0.23 kgf in average and 0.11 kgf in minimum.Conclusion Root Cause Analysis:The most probable root cause is that the attachment of the needle was not correctly done as the defective sample received shows that the needle is escaped from the thread.Final conclusion:Taking into account the defective sample received and that there is a previous confirmed complaint of this code-batch regarding the same issue, we conclude that this complaint is confirmed.Corrective measures: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, we opened a CAPA in the system to correct/prevent this defect to happen.