MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 5/0 (1) 45CM DGMP16 RCP; OTHER SUTURE

Model Number C3095549

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

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

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.Investigation: samples received: 8 unopened racepacks and one opened.Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market 756 units of this code-batch.There are no units in our stock.We have received eight closed samples and one open and unused sample with the needle detached from the thread (thread is still wound on the pack) for analysis.We have tested the needle attachment strength of all closed samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 0.70 kgf in average and 0.34 kgf in minimum (ep requirements: 0.23 kgf in average and 0.11 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.Taking into account that no other customer complaints have been received for this code-batch and the closed samples tested fulfil ep requirements, we consider that the open sample received is an isolated unit, but the whole batch is correct.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.No corrective/preventive actions needed.

Event Description

It was reported that the thread detached from the needle.The reporter indicated that the thread detached from the needle upon opening the box.Additional details were not provided.

• Brand Name: OPTILENE 5/0 (1) 45CM DGMP16 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: 9489633
• MDR Text Key: 172616421
• Report Number: 3003639970-2019-00898
• 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: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2024
• Device Model Number: C3095549
• Device Catalogue Number: C3095549
• Device Lot Number: 119114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2019
• 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