MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 4/0 (1,5) 90CM 2XHR17 CV RCP; CARDIAC SUTURE

Model Number C3090902

Device Problems Material Integrity Problem (2978); Separation Problem (4043)

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

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.K133890.If additional information becomes available a follow up report will be submitted.

Event Description

It was reported the needle-suture has "bad fiction." the reporter indicated that the oncology surgical department is experiencing bad fiction with the needle and suture.The needle is permanently tearing from the thread.Per one surgeon, this occurred three times during a surgical procedure.It was reported that all optilene from 3/0 to 10/0, breaks at the junction of the thread with the needle; the 10/0 suture detached when removing from packaging.Per reporter, it is not possible to provide the information about every patient separately.

Manufacturer Narrative

Investigation: samples received: (b)(4) unopened race packs.Analysis and results: there are no previous complaints of this code-batch.We manufactured and mostly distributed in the market (b)(4) units of this code-batch.There are (b)(4) units in our stock.We have received (b)(4) closed samples for analysis.We have tested the needle attachment strength of closed samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 0.85 kgf in average and 0.53 kgf in minimum (ep requirements: 0.46 kgf in average and 0.23 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 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.Anyway, you will receive a credit note for one box of product for the units sent for analysis.No corrective/preventive actions needed.

• Brand Name: OPTILENE 4/0 (1,5) 90CM 2XHR17 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: 9349597
• MDR Text Key: 172450819
• Report Number: 3003639970-2019-00798
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• 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: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C3090902
• Device Catalogue Number: C3090902
• Device Lot Number: 118307
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1