MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOPLUS C VIOLET 4/0 (1,5) 25M; SYNTHETIC ABSORBABLE MONOFILAR

Model Number F0024270

Device Problem Break (1069)

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.K031216.Analysis and results: 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 26 units of this code-batch.There are no units in our stock.We have received one open and used cassette.The date of cassette's opening written is: 21.11.19.The cassette is within the 4 months since opening of which the cassette can be used.We have tested the knot pull tensile strength of the thread of the cassette received and the results fulfil the requirements of the european pharmacopoeia (ep): 1.50 kgf in average and 1.36 kgf in minimum (ep requirements: 0.97 kgf in average and 0.49 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.We regret any inconvenience this issue may have caused and thank you for your collaboration.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 that there was an issue with monoplus violet.The client reports that the thread breaks too easily (easier than usual).There is only one user (veterinarian) who has been familiar with the product for a long time.The cassette was opened in 11/21/2019.

• Brand Name: MONOPLUS C VIOLET 4/0 (1,5) 25M
• Type of Device: SYNTHETIC ABSORBABLE MONOFILAR
• 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 salud orus ; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 9742894
• MDR Text Key: 180546137
• Report Number: 3003639970-2020-00115
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 02/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2021
• Device Model Number: F0024270
• Device Catalogue Number: F0024270
• Device Lot Number: 119371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2020
• 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: Unknown
• Patient Sequence Number: 1