MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 6/0 (0,7) 75CM 2XHR10 CV RCP; CARDIAC SUTURE

Model Number C3090868

Device Problems Material Separation (1562); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 05/04/2019

Event Type  malfunction  

Manufacturer Narrative

Reported device not marketed in the u.S., however, similar devices or devices that share components, (b)(4) materials, process methods or other technological characteristics are registered within the u.S.K133890.Investigation: samples received: 69 unopened race packs.Analysis and results: there are no previous complaints of the same code-batch.We manufactured and mostly distributed in the market (b)(4) units of this code-batch.There are 12 units in our stock.We have received 69 closed samples for analysis.We have checked all closed samples received and we have not found any sample with the needle already detached from the thread.We have also tested the needle attachment strength of the samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 0.33 kgf in average and 0.167 kgf in minimum (ep requirements: 0.17 kgf in average and 0.082 kgf in minimum).Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.Final conclusion: although the results of the 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.No corrective/preventive actions needed.

Event Description

It was reported that the needle detaches easily in closed package.It was reported that the needle detached easily in the closed packages, it lays loose in the closed package.The event was pre- operative.No patient was involved.

• Brand Name: OPTILENE 6/0 (0,7) 75CM 2XHR10 CV RCP
• Type of Device: CARDIAC SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer (Section G): B/ BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer Contact: silvia orus ; carretera de terrassa, 121; rubi, barcelona 08191 ; SP 08191
• MDR Report Key: 8782846
• MDR Text Key: 150881509
• Report Number: 3003639970-2019-00534
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2024
• Device Model Number: C3090868
• Device Catalogue Number: C3090868
• Device Lot Number: 119052V024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2019
• 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