MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. NOVOSYN VIOLET 3/0 (2) 70CM DS24 (M)RCP; SYNTHETIC ABSORBABLE BRAIDED SUTURE

Model Number C0068235N1

Device Problem Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Reported device not marketed in the u.S., however, similar device or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S., k122734.Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in our stock.We have not received any sample for analysis.Without any sample we cannot carry out an analysis in order to take a decision.As no samples have been received and no units are available in b.Braun surgical, we have only been able to review the batch manufacturing record and the results during the process fulfill usp/ep and b.Braun surgical requirements.Needle penetration strength result conducted on samples tested during production was 0.381n in average and fulfilled specifications: < 0.480 n in average.These needles controlled during the control production have conforming penetration performance.As stated in the instructions for use of the product, care should be taken to avoid damage when handling surgical needles.Grasp the needle in an area one-third (1/3) to one half (1/2) of the distance from the attachment end to the point.Grasping in the point area could impair the penetration performance and cause fracture of the needle.Grasping at the butt or attachment end could cause bending or breakage.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.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.

Event Description

It was reported an issue with novosyn suture.The client reported that the needles do not have the same sharpness and are blunter.It was reported from a veterinary practice.No further information has been received.

• Brand Name: NOVOSYN VIOLET 3/0 (2) 70CM DS24 (M)RCP
• Type of Device: SYNTHETIC ABSORBABLE BRAIDED SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer Contact: martina laporte ; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 13589734
• MDR Text Key: 286064442
• Report Number: 3003639970-2022-00081
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2022

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: C0068235N1
• Device Catalogue Number: C0068235N1
• Device Lot Number: 3115M6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1