MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 4/0 (1,5) 45CM DSMP19 (M) RCP; OTHER SUTURE

Model Number C3090676

Device Problems Material Frayed (1262); Material Integrity Problem (2978)

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

Event Date 06/11/2019

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: 28 unopened racepacks and 1 opened.Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in our stock.We have received 28 closed samples for analysis and 1 open sample that shows thread splitting.We have tested the knot pull tensile strength of the closed samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 1.26 kgf in average and 1.22 kgf in minimum (ep requirements: 0.51 kgf in average and 0.15 kgf in minimum) we have not found splitting on thread surface on the closed samples received before and after performing this test.Additionally, we have tested the needle attachment strength of the closed samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 1.27 kgf in average and 0.92 kgf in minimum (ep requirements: 0.46 kgf in average and 0.23 kgf in minimum) however, we have found splitting on thread surface near needle attachment area in two closed samples received during performing needle attachment strength test, as can be seen in enclosed picture.Probably, it is caused due to an excessive strength applied to attach the thread to the needle.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 the failure in the closed 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.You will receive a credit note for one box of product as compensation.No corrective/preventive actions needed.

Event Description

It was reported that the thread is splitting.It was reported that the thread splits.This was noticed before use.Additional information has not been provided.

• Brand Name: OPTILENE 4/0 (1,5) 45CM DSMP19 (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: 8767080
• MDR Text Key: 150267173
• Report Number: 3003639970-2019-00525
• 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: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2024
• Device Model Number: C3090676
• Device Catalogue Number: C3090676
• Device Lot Number: 119043V004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: No
• 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