MAUDE Adverse Event Report: B.BRAUN SURGICAL SA C1048595; SAFIL

Model Number C1048595

Device Problems Break (1069); Out-Of-Box Failure (2311)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on going.Device not returned.

Event Description

(b)(6).After opened the package, it was found there's two broken area of the suture and the broken part was found tied up.

Manufacturer Narrative

Samples received: none.Analysis and results: there is a previous complaint of this code batch but regarding another issue (packaging defect).We manufacturer and distributed 11,880 units in the market, there are no units in stock b.Braun surgical 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.Nevertheless, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyze 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: C1048595
• Type of Device: SAFIL
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• MDR Report Key: 7276890
• MDR Text Key: 100464395
• Report Number: 3003639970-2018-00097
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• PMA/PMN Number: K031286
• 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: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: C1048595
• Device Catalogue Number: C1048595
• Device Lot Number: 117043
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/08/2019
• Date Manufacturer Received: 01/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1