MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. MONOSYN VIOLET 0 (3,5) 70CM HS37S (M)RCP; SYNTHETIC ABSORBABLE MONOFILAR SUTURE

Model Number C2022248

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/02/2024

Event Type  malfunction  

Event Description

It was reported an issue with monosyn suture.The client (veterinarian) reported that there were 2 envelopes in which the needle and thread have come out unattached.Additional information has not been provided.

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 our stock.We have received 1 closed sample and 2 open samples, with the threads still wound on the packs and 1 with the needle detached and the other without needle.Tightness test to the closed sample received has been performed and the unit is tight.Needle attachment results conducted on the closed sample received is 4.20 kgf in average and in minimum and fulfil ep requirements: 1.53 kgf in average and 0.46 kgf in minimum.However, taking into account that the 2 open samples received had the thread still wound on the pack and the needles detached, we will consider this complaint as confirmed.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: the most probable root cause is that the attachment of the needle was not correctly done as the open samples received show that the needle escaped from the thread.Final conclusion: taking into account the open samples received do not fulfil european pharmacopoeia/ b.Braun surgical specifications we conclude that the complaint is confirmed by evidence of the failure in the open 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: MONOSYN VIOLET 0 (3,5) 70CM HS37S (M)RCP
• Type of Device: SYNTHETIC ABSORBABLE MONOFILAR 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: 18786475
• MDR Text Key: 337529014
• Report Number: 3003639970-2024-00066
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K011375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C2022248
• Device Catalogue Number: C2022248
• Device Lot Number: 122115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2022
• 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