MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 3/0 (2) 75CM HS21 (M) RCP; OTHER SUTURE

Model Number C3090461

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

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

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: 114 unopened race packs.Analysis and results: there is a previous complaint of this code batch regarding the same issue, and it was closed as not confirmed after analysis.We have manufactured and distributed in the market (b)(4) units of this code batch.There are no units in stock.We have received 114 closed samples.We have checked the samples received and we have noticed that some of them show the thread surface is damaged.Furthermore, sewing test on artificial skin tissue has been conducted with some closed samples received and fraying/damaged surface appears in some units when pulling the thread through the tissue.On the other hand, we have tested the knot pull tensile strength of the closed samples received and the results fulfill the requirements of the european pharmacopoeia (ep): 1.88 kgf in average and 1.73 kgf in minimum (ep requirements: 0.92 kgf in average and 0.31 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): 0.85 kgf in average and 0.71 kgf in minimum (ep requirements: 0.69 kgf in average and 0.35 kgf in minimum).We have not found splitting on thread surface on the closed samples received before and after performing tests.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 results of samples received do not fulfil the specifications of the european pharmacopoeia/b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of some of 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.No corrective/preventive actions needed.

Event Description

It was reported the thread is splitting.The reporter indicated that during a carpel tunnel procedure the thread frayed while suturing.No additional information has been provided.Additional information has been requested, however, as of this report not yet received.

• Brand Name: OPTILENE 3/0 (2) 75CM HS21 (M) RCP
• Type of Device: OTHER 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: 8822769
• MDR Text Key: 152085860
• Report Number: 3003639970-2019-00552
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2023
• Device Model Number: C3090461
• Device Catalogue Number: C3090461
• Device Lot Number: 118494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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