MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOPLUS VIOLET 5/0 (1) 45CM DSMP13 (M); SUTURE

Model Number C0024916

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 07/30/2018

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Needle detachment.

Manufacturer Narrative

Samples received: none.Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed (b)(4) in the market.There are no units in stock in b.Braun surgical's warehouse.As no samples have been received and no units are available in b.Braun surgical, s.A.We have only reviewed the batch manufacturing record and this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.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 and the case is not confirmed due to lack of evidence.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 5/0 (1) 45CM DSMP13 (M)
• Type of Device: SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 7834245
• MDR Text Key: 118885451
• Report Number: 3003639970-2018-00512
• 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: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0024916
• Device Catalogue Number: C0024916
• Device Lot Number: 118065
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/13/2018
• Date Manufacturer Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1