MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. MONOPLUS VIOLET 1 (4) 90CM HR48 (M)RCP; SYNTHETIC ABSORBABLE MONOFILAR SUTURE

Model Number C2024078

Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2022

Event Type  malfunction  

Event Description

It was reported an issue with monoplus suture.The client reported that the thread broke easily and detached out of the needle when pulling, during use.No more information has been provided.

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., (b)(4).If additional information becomes available a follow-up report will be submitted.

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed in the market (b)(4) units.There are no units in stock in b.Braun surgical's warehouse.We have received 2 closed samples.Tightness test to the closed samples received has been performed and the units are tight.We have tested the knot pull tensile strength of the closed samples received and the results fulfill the requirements of the european pharmacopoeia (ep): 6.83 kgf in average and 6.80 kgf in minimum (ep requirements: 5.18 kgf in average and 2.59 kgf in minimum).We have also tested the needle attachment strength of the closed samples received and the results fulfill the requirements of the european pharmacopoeia (ep): 5.94 kgf in average and 5.37 kgf in minimum (ep requirements: 1.83 kgf in average and 0.61 kgf in minimum).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.Knot pull tensile strength results conducted on samples before releasing the product were 5.92 kgf in average and 5.70 kgf in minimum and fulfilled ep requirements: 5.18 kgf in average and 2.59 kgf in minimum.Furthermore, needle attachment results conducted on samples before releasing the product were 4.29 kgf in average and 2.25 kgf in minimum and fulfilled ep requirements: 1.83 kgf in average and 0.61 kgf in minimum.Final conclusion: although the results of the 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.The case is considered not confirmed by evidence of the samples received.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.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.

• Brand Name: MONOPLUS VIOLET 1 (4) 90CM HR48 (M)RCP
• Type of Device: SYNTHETIC ABSORBABLE MONOFILAR SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer Contact: martina laporte ; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 16102238
• MDR Text Key: 308447539
• Report Number: 3003639970-2022-00587
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C2024078
• Device Catalogue Number: C2024078
• Device Lot Number: 122097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2023
• 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