MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOSYN VIOLET 4/0 (1,5)70CM HR17(M).RCP; SYNTHETIC ABSORBABLE MONOFILAR

Model Number C2022004

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: k011375.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.Additional information / investigation results will be provided in a supplemental report, if applicable.

Event Description

It was reported that there was an issue with monosyn violet.The customer reported that during a surgical procedure when the product was opened the needle and thread had been detached.This product could not be used.There is no patient information available.The event occurred prior to use on the patient.

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed in the market 5,076 units.There are no units in stock in b.Braun surgical's warehouse.We have received an open and unused sample without needle, the thread is not wound on the pack.However, without closed samples a proper analysis cannot be performed.Taking into account that there are no previous complaints we consider that this is an isolated unit.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.Final conclusion: in spite of receiving a defective sample, without closed samples a suitable analysis cannot be performed.Nevertheless, we take note of this incidence and if any closed sample is received in the future, we will re-open the case and analyse it.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: MONOSYN VIOLET 4/0 (1,5)70CM HR17(M).RCP
• Type of Device: SYNTHETIC ABSORBABLE MONOFILAR
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 9693469
• MDR Text Key: 178563999
• Report Number: 3003639970-2020-00077
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C2022004
• Device Catalogue Number: C2022004
• Device Lot Number: 1190201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1