MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. NOVOSYN VIOLET 1 (4) 90CM HS37 (M)RCP; SYNTHETIC ABSORBABLE BRAIDED SUTURE

Model Number C0068497N1

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/27/2024

Event Type  malfunction  

Event Description

It was reported an issue with novosyn suture.The client reported that the needle loosens during the 1st pass of a surgical suture.Additional information has been requested.

Manufacturer Narrative

If additional information becomes available a follow up report will be submitted.

Manufacturer Narrative

Summary of investigation: there are no previous complaints of this code batch of which we manufactured and distributed in the market (b)(4) units.There are no units in stock in b.Braun surgical's warehouse.We have received a closed sample.Tightness test to the closed sample received has been performed and the unit is tight.Needle attachment strength results conducted on the sample received is 2.77 kgf and fulfil the requirements of the european pharmacopoeia (ep): 1.83 kgf in average and 0.61 kgf in minimum.Furthermore, needle attachment strength results conducted on samples before releasing the product were 3.07 kgf in average and 2.88 kgf in minimum and fulfilled ep requirements: 1.83 kgf in average and 0.61 kgf in minimum.Batch manufacturing record: reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.Conclusion root cause analysis: it has not been possible to determine the root cause because the closed sample received comply usp/ep and b.Braun surgical requirements for needle attachment strength.Final conclusion: although the results of the samples received fulfil the specifications of european pharmacopoeia/ b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.The case is considered not confirmed by evidence of the sample received.Corrective measures: actions on distributed product 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.

• Brand Name: NOVOSYN VIOLET 1 (4) 90CM HS37 (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: 18968869
• MDR Text Key: 338492683
• Report Number: 3003639970-2024-00098
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0068497N1
• Device Catalogue Number: C0068497N1
• Device Lot Number: 33439L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2023
• 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