MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. MONOPLUS C VIOLET 2/0 (3) 25M; SYNTHETIC ABSORBABLE MONOFILAR SUTURE

Model Number F0024272

Device Problem Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Event Description

It was reported an issue with monoplus c suture.The client (veterinarian) reported that suture snapped when tightening the knots.They have had 3 surgeries where the suture broken down over the last week since opening the cassette.No more information has been provided.

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.Under pma/510(k) number: k031216.Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market 317 units of this code-batch.There are no units in our stock.We have received one open cassette without the opening date written.The date of cassette's opening should be written in the cassette as indicated on cassette label.We have tested the knot pull tensile strength of the sample received and the results fulfil the requirements of the european pharmacopoeia (ep): 3.55 kgf in average and 3.03 kgf in minimum (ep requirements: 2.73 kgf in average and 1.37 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.Final conclusion: although the results of the sample 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.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 C VIOLET 2/0 (3) 25M
• 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: 15579329
• MDR Text Key: 301478146
• Report Number: 3003639970-2022-00418
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2023
• Device Model Number: F0024272
• Device Catalogue Number: F0024272
• Device Lot Number: 122262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2022
• 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