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

Model Number C3090461

Device Problems Unraveled Material (1664); 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, raw materials, process methods or other technological characteristics are registered within the u.S.K133890.Investigation: samples received: 80 unopened race packs.Analysis and results: there are no previous complaints of this code batch.We have manufactured and distributed in the market (b)(4) units of this code batch.There are no units in our stock.We have received 80 closed samples to analyze both cases.We have tested the knot pull tensile strength of the closed samples received and the results fulfill the requirements of the european pharmacopoeia (ep):1.83 kgf in average and 1.49 kgf in minimum (ep requirements: 0.92 kgf in average and 0.31 kgf in minimum).Additionally, needle attachment test has been conducted on the closed samples received in order to discard a faulty needle-attachment during manufacturing process, but the results fulfill the requirements of the european pharmacopoeia (ep):1.88 kgf in average and 1.52 kgf in minimum (ep requirements: 0.69 kgf in average and 0.35 kgf in minimum).Nevertheless, we have found splitting on thread surface in some of the closed samples received after performing needle attachment strength test.Probably, it is caused due to an excessive strength applied to attach the thread to the needle.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 the samples received.We apologize for any inconvenience that this issue may have caused, and thank you for your collaboration.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 capa required.

Event Description

It was reported the thread is splitting.The reporter indicated that the thread is splitting.This event occurred in two different surgeries; a carpel tunnel procedure and a subcutaneous surgical procedure.No patient information is available.This report is for the carpel tunnel procedure.

• 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: 8756069
• MDR Text Key: 190680101
• Report Number: 3003639970-2019-00498
• 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: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2023
• Device Model Number: C3090461
• Device Catalogue Number: C3090461
• Device Lot Number: 118476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2019
• 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