MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 7/0 (0,5) 60CM 2XDR10 CV RCP; CARDIAC SUTURE

Model Number C3095817

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

Patient Problem No Patient Involvement (2645)

Event Date 07/19/2019

Event Type  malfunction  

Manufacturer Narrative

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 report will be submitted.

Event Description

It was reported the thread shows deformations / kinks.The reporter indicated that the thread shows deformations / kinks at the thread path.The event occurred pre-operatively with no patient involvement.

Manufacturer Narrative

Investigation: samples received: 1 open race pack.Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market 288 units of this code-batch.There are no units in our stock.We have received one open and unused sample with the thread broken and the needle attached to the thread.The other piece of thread and needle (reference with double needle) is still wound on the pack.Checking the suture under the microscope, we can see that there are areas where the thread seems thicker (kinking's) that could be noticed if you pass the fingers along the thread surface.It is an effect produced by the winding process but does not affect the properties and the quality of the product.Reviewed the batch manufacturing record, this batches has an incidence and was released into the market fulfilling usp/ep and b.Braun surgical requirements.Final conclusion: although the results of the sample received fulfil the 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.No corrective/preventive actions needed.

• Brand Name: OPTILENE 7/0 (0,5) 60CM 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: 8875945
• MDR Text Key: 159409220
• Report Number: 3003639970-2019-00602
• 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: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2023
• Device Model Number: C3095817
• Device Catalogue Number: C3095817
• Device Lot Number: 118477V160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1