MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOSYN VIOLET 5/0 (1) 70CM HR17 (M); SUTURE

Model Number C0022003

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

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 suture.There are 2 cases of needle separation from thread in this batch number.The malfunction occurred upon opening the packet.

Manufacturer Narrative

Analysis and results: there are previous complaints of this code batch of which we manufactured and distributed in the market (b)(4) units.Previous complaints are related the same issue.One was closed as confirmed.There are no units in stock in b.Braun surgical's warehouse.We have received two open and unused samples with the needle detached from the thread and the threads still wound on the pack.Without closed samples a proper analysis (needle attachment strength test) cannot be performed.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: taking into account that the samples received showed the needle detached and the thread wound on the pack and that there are previous complaints of this code batch regarding the same issue, we conclude that the complaint is confirmed by evidence of the samples received.Actions on distributed product 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 5/0 (1) 70CM HR17 (M)
• Type of Device: SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 9608084
• MDR Text Key: 175666555
• Report Number: 3003639970-2020-00011
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• PMA/PMN Number: K011375
• 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: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0022003
• Device Catalogue Number: C0022003
• Device Lot Number: 117365
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1