MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 6/0 (0,7) 75CM 2XDR10 CV RCP; CARDIAC SUTURE

Model Number C3090915

Device Problems Material Integrity Problem (2978); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: 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.K133890.When additional information becomes available a follow up will be submitted.

Event Description

It was reported that the thread is splitting and breaking.The reporter indicated that the threads are stratified and twisted.In addition to this, thread break occurs after several stitches.No patient information available.Additional event details have been requested.

Manufacturer Narrative

Investigation: samples received: (b)(4) unopened racepacks.Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in our stock.We have received (b)(4) closed samples for analysis.We have tested the knot pull tensile strength of the closed samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 0.39 kgf in average and 0.35 kgf in minimum (ep requirements: 0.15 kgf in average and 0.06 kgf in minimum) we have not found splitting on thread surface on the closed samples received before and after performing test.Furthermore, sewing test on artificial skin tissue has been conducted with the closed samples received and fraying/splitting does not appear when pulling the thread through the tissue.Visual appearance is the usual one.Reviewed the batch manufacturing record, this batch has an incidence but was released into the market fulfilling usp/ep and b.Braun surgical requirements.Final conclusion: although the results of the closed samples received fulfil the specifications of european pharmacopoeia/ b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.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.Anyway, you will receive a credit note for the units sent for analysis as a quality courtesy.No corrective/preventive actions needed.

• Brand Name: OPTILENE 6/0 (0,7) 75CM 2XDR10 CV RCP
• Type of Device: CARDIAC SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 9541107
• MDR Text Key: 173461272
• Report Number: 3003639970-2019-00957
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C3090915
• Device Catalogue Number: C3090915
• Device Lot Number: 119024
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1