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

Model Number C3090714

Device Problem Material Integrity Problem (2978)

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

Event Date 10/23/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation ongoing.

Event Description

It was reported that there was an issue with the optilene.During an unspecified procedure, the needle tore from the suture.There was no patient harm.

Manufacturer Narrative

Analysis and results: as no batch number is available, the batch manufacturing record cannot be reviewed.We have not received any sample for analysis.Without any sample we cannot carry out an analysis in order to take a decision.Final conclusion: without samples 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 and/or batch 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.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.

• 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: 9331311
• MDR Text Key: 172322629
• Report Number: 3003639970-2019-00793
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• PMA/PMN Number: K133890
• 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: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C3090714
• Device Catalogue Number: C3090714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1