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

Model Number C0069236N1

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

It was reported an issue with novosyn suture.The client reported the needles of novosyn 2/3 (ref (b)(4) were coming off.Additional information has not been received.

Manufacturer Narrative

Summary of investigation: there are no previous complaints of this code-batch.We manufactured and distributed in the (b)(4) units of this code-batch.There are no units in our stock.We have received 16 closed samples for analysis.Tightness test to the closed samples received has been performed and the units are tight.When we have conducted rotation test on all closed samples received, we have noticed that in 11 of the samples, the thread broke easily next to the needle.Then, detachment of the needle or breakage of the thread in that area could have been caused by too much thermal treatment in the manufacturing process, which causes the thread burnt and breaking easily in the attachment area.Batch manufacturing record: reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Conclusion root cause analysis: detachment of the needle could be caused by too much thermal treatment applied to the thread ends that caused the thread to be fragile and break in the attachment area.Final conclusion: taking into account that the results of the samples received do not fulfil b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the samples received.Corrective measures: 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.

• Brand Name: NOVOSYN UNDYED 2/0 (3) 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: 18968872
• MDR Text Key: 338690062
• Report Number: 3003639970-2024-00103
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

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: C0069236N1
• Device Catalogue Number: C0069236N1
• Device Lot Number: 33427W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2023
• 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
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 65 KG