MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. OPTILENE 7/0 (0,5) 4X60CM 2XDR10CV2LP; CARDIAC SUTURE

Model Number G3097371

Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2022

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: reported device marketed in the u.S., only for veterinary use, however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.Under pma/510(k) number: k133890.Analysis and results: there are no previous complaints of this code batch of which we manufactured (b)(4) units.There are 144 units blocked in stock in b.Braun surgical's warehouse.We have received 11 closed samples to analyze this case.We have checked the samples received and they contain only 2 sutures instead of 4 sutures.This defect is caused by a human mistake during production process.The product should have 4 sutures inside.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Final conclusion: taking into account that the samples received do not fulfil b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of failure in the samples received.Actions on distributed product 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.

Event Description

It was reported an issue with optilene suture.The client reported that there were a wrong numbers of sutures inside the sterile packaging, being 2 sutures instead of 4 sutures.No further information has been received.

• Brand Name: OPTILENE 7/0 (0,5) 4X60CM 2XDR10CV2LP
• Type of Device: CARDIAC SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer Contact: martina laporte ; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 16352086
• MDR Text Key: 309569267
• Report Number: 3003639970-2023-00025
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G3097371
• Device Catalogue Number: G3097371
• Device Lot Number: 121145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1