MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 5/0 (1) 75CM 2XHR13 CV RCP; CARDIAC SUTURE

Model Number C3090954

Device Problem Material Integrity Problem (2978)

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

Event Date 10/22/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with optilene.During an unspecified procedure, the threads were noted to be fibrous and break after several stitches.It was likely a pediatric cardiac surgery.There was no patient harm.

Manufacturer Narrative

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 72 closed samples and 1 opened with only one of the needles detached from the thread.No fraying/splitting has been found in this open sample.We have tested the knot pull tensile strength of the closed samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 0.74 kgf in average and 0.67 kgf in minimum (ep requirements: 0.31 kgf in average and 0.10 kgf in minimum) additionally, needle attachment strength test has been conducted on the closed samples received in order to discard a faulty needle attachment during manufacturing process that could cause splitting/fraying in the thread.The needle attachment strength results fulfil the requirements of the european pharmacopoeia (ep): 0.48 kgf in average and 0.28 kgf in minimum (ep requirements: 0.23 kgf in average and 0.11 kgf in minimum).We have not found splitting on thread surface on the closed samples received before and after performing tests.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 a 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.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 5/0 (1) 75CM 2XHR13 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: 9298834
• MDR Text Key: 172281162
• Report Number: 3003639970-2019-00782
• 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: 11/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C3090954
• Device Catalogue Number: C3090954
• Device Lot Number: 118462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Date Manufacturer Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1