MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. MONOPLUS VIOLET 5/0 (1) 70CM 2XHR17 (M); SYNTHETIC ABSORBABLE MONOFILAR

Model Number C0024613

Device Problems Component Missing (2306); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

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 our stock.We have not received any sample for analysis.Without any sample we cannot carry out an analysis in order to take a decision.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.Needle attachment strength results before releasing the product were 0.81 kgf in average and 0.70 kgf in minimum and fulfilled the requirements of the european pharmacopoeia (ep requirements: 0.23 kgf in average and 0.11 kgf in minimum).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 that there was an issue with monoplus suture.The client reported that when opening the package, in 5 sutures the needle was missing and in 7 sutures the needle was detached easily from the thread.There is no patient involvement.

• Brand Name: MONOPLUS VIOLET 5/0 (1) 70CM 2XHR17 (M)
• Type of Device: SYNTHETIC ABSORBABLE MONOFILAR
• 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: silvia orus ; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 10372402
• MDR Text Key: 201873354
• Report Number: 3003639970-2020-00309
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K031216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0024613
• Device Catalogue Number: C0024613
• Device Lot Number: 120145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2020
• 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