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

Model Number C2022216

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

G4: reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.Under pma/510(k) number: k011375.If additional information becomes available a follow up report will be submitted.

Event Description

It was reported an issue with monosyn suture.The client (veterinarian) reported that the thread was not attached to the needle when it was opened and it has happened (after asking other vets) that the thread has come loose during surgery, coming off the needle.

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 an open and unused sample with the needle detached from the thread (thread is still wound on the pack).However, without closed samples a proper analysis cannot be performed.Considering that no other customer complaints have been received concerning this issue for this code-batch, we consider that this is an isolated unit, but the whole batch is correct.Batch manufacturing record: reviewed the batch manufacturing record, this product had no incidences related to this issue and was released fulfilling usp/ep and b.Braun surgical specifications.Conclusion root cause analysis: the root cause cannot be determined as no closed samples have been received and only one open sample received.Final conclusion: in spite of receiving a defective sample, without closed samples a suitable analysis cannot be performed.Nevertheless, we take note of this incidence and if any closed sample is received in the future, we will re-open the case and analyse it.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: MONOSYN VIOLET 2/0 (3) 70CM DS24 (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: 18825192
• MDR Text Key: 336753336
• Report Number: 3003639970-2024-00068
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: SEE H11
• 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
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C2022216
• Device Catalogue Number: C2022216
• Device Lot Number: 13298M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2023
• 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