MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOPLUS VIOLET 1 (4) 90CM HR48 (M); SUTURES

Model Number C0024078

Device Problem Device Issue (2379)

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

Event Date 01/24/2018

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Increased wound dehiscence rate.

Manufacturer Narrative

Samples received: there are no samples available.Analysis and results: as no batch number is received, the batch manufacturing record cannot be reviewed.We have not received any sample for analysis.Without any closed sample and/or more information, we cannot carry out an analysis in order to take a decision.Final conclusion: without samples we are not in position of studying if the affected product does not fulfil the specifications.In consequence, a proper analysis cannot be done.Nevertheless, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyse it.Please note that when no samples are received our analysis is very limited.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 VIOLET 1 (4) 90CM HR48 (M)
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• MDR Report Key: 7292023
• MDR Text Key: 100844858
• Report Number: 3003639970-2018-00119
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: K031216
• 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: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0024078
• Device Catalogue Number: C0024078
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/24/2018
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/23/2018
• Supplement Dates Manufacturer Received: 01/31/2018
• Supplement Dates FDA Received: 02/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other