MAUDE Adverse Event Report: B.BRAUN SURGICAL SA DAFILON BLACK 10/0 (0.2) 30CM 2XDLM6; SUTURES

Model Number G1118706

Device Problems Failure To Adhere Or Bond (1031); Break (1069)

Patient Problem Fluid Discharge (2686)

Event Date 12/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of compliant: (b)(6).Surgical recovery following a broken suture, for consequence a leakage of the corneal greffon and risk of rejection.

Manufacturer Narrative

Samples received: a piece of broken thread.Analysis and results: end customer does not know the exact batch number involved in this case.Possible batches are 117235, 117265, 117233, 117344, 117345, 117381, 117392 and 117394.There is a previous complaint of the same end customer, regarding the same issue, batch number was also not known at that moment.Possible batches at that moment were the same as this except 117381.A part of this complaint, there are no previous complaints of any of the possible involved batches.There are no units in stock of any of the possible batches.We have received a piece of broken thread that cannot be analyzed anymore as it has been used and no testing could be done.As no samples have been received and no units are available in b.Braun surgical, (b)(4).We have only reviewed the batch manufacturing records and all possible batches had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.We have also reviewed the incoming inspection results of the involved thread raw material batches and fulfilled product specifications.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.Nevertheless, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyze it.Please note that when no samples are received our analysis is very limited.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: DAFILON BLACK 10/0 (0.2) 30CM 2XDLM6
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 7267068
• MDR Text Key: 100060044
• Report Number: 3003639970-2018-00105
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• 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: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G1118706
• Device Catalogue Number: G1118706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Distributor Facility Aware Date: 02/08/2018
• Date Manufacturer Received: 01/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other