MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. MONOSYN VIOLET 2/0 (3) 70CM HR26 (M) RCP; SYNTHETIC ABSORBABLE MONOFILAR SUTURE

Model Number C2022026

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/27/2023

Event Type  malfunction  

Manufacturer Narrative

G4: reported device 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.Under pma/510(k) number: k011375.Summary of investigation: there is one previous complaint of this code-batch, regarding the same issue, closed as not confirmed after analysis.We manufactured and distributed in the market 5,976 units of this code-batch.There are no units in our stock.We have not received any sample for analysis, only a picture showing an open sample with the needle detached from the thread, and the thread is still wound on the pack.Without any closed sample we cannot carry out an analysis in order to take a decision.However, considering the defective sample of the picture received and that there is a previous complaint regarding the same issue, we consider that this complaint is confirmed.Batch manufacturing record: reviewed the batch manufacturing record, there are no incidences regarding this issue and the results during the process fulfilled usp/ep and b.Braun surgical requirements.Conclusion root cause analysis: it has not been possible to determine the root cause as no closed samples are received for analysis, only a picture showing an open sample has been received.Final conclusion: taking into account the defective sample of the picture received and that there is a previous complaint for this code-batch regarding the same issue, we conclude that this complaint is confirmed.Corrective measures: 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.

Event Description

It was reported an issue with monosyn suture.The client reported that the needle is separated from the suture.No further information has been provided.

• Brand Name: MONOSYN VIOLET 2/0 (3) 70CM HR26 (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: 18814782
• MDR Text Key: 336753270
• Report Number: 3003639970-2024-00089
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: SEE H11
• 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
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C2022026
• Device Catalogue Number: C2022026
• Device Lot Number: 13231Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/10/2023
• 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