MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. DAFILON BLUE 5/0 (1) 45CM DGMP13; OTHER SUTURE

Model Number C0933906

Device Problem 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 received three closed samples for analysis and one open and unused sample with the needle detached from the thread, and the thread is still wound on the pack.We have tested the needle attachment strength of the closed samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 0.53 kgf in average and 0.52 kgf in minimum (ep requirements: 0.23 kgf in average and 0.11 kgf in minimum).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.Taking into account that there are no previous complaints for this code-batch and the closed samples tested, we consider that the open sample received is an isolated unit, but the whole batch is correct.Final conclusion: although the results of the closed 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.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 dafilon suture.The client reported that when opening the package, the needle is already detached from the thread.It occurs multiple times before that.The event occurred prior to use on the patient.Additional data has not been provided.

• Brand Name: DAFILON BLUE 5/0 (1) 45CM DGMP13
• Type of Device: OTHER SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa, 121; rubí, 08191 ; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL, S.A.; carretera de terrassa, 121; rubí, 08191 ; SP 08191
• Manufacturer Contact: sílvia orús ; carretera de terrassa, 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 10377504
• MDR Text Key: 202053397
• Report Number: 3003639970-2020-00300
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151165
• 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: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0933906
• Device Catalogue Number: C0933906
• Device Lot Number: 619291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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