MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. NOVOSYN VIOLET 3/0 (2) 90CM HR26 (M); SYNTHETIC ABSORBABLE BRAIDED SUTURE

Model Number C0068541

Device Problems Material Frayed (1262); Dull, Blunt (2407)

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

Event Date 08/09/2023

Event Type  malfunction  

Manufacturer Narrative

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 stock at b.Braun surgical's warehouse.We have not received any sample for analysis.Without any closed and/or defective sample we cannot carry out an analysis in order to take a decision.Reviewed the needle batch manufacturing records, no deviations have been found and the results of penetration performance test for the needle raw material batch used in this product during production was 0.263 n in average for the 1st penetration and fulfilled the specification (<0.300 n).Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfilled usp/ep and b.Braun surgical requirements.We have also reviewed the complaint history record, and there are no previous complaints in any of the products manufactured with the same needle nor thread raw material batches used in this product.Remarks: as stated in the instructions for use of the product, when working with novosyn® suture materials great care should be taken to ensure that the use of surgical instruments, such as forceps and needle holders, do not cause any crushing or crimping damage to the suture material.Also, 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.Reshaping needles may cause them to lose strength and be less resistant to bending and breaking.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 needle is non-cutting, it means higher use of strenght, and suture is fraying while use.No patient injury.Cesarean section (uterus).Change of suture during surgery.

• Brand Name: NOVOSYN VIOLET 3/0 (2) 90CM HR26 (M)
• 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: 18037395
• MDR Text Key: 327634092
• Report Number: 3003639970-2023-00362
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K122734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0068541
• Device Catalogue Number: C0068541
• Device Lot Number: 723015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Female