MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. DAFILON BLUE 5/0 (1) 45CM DS19; OTHER SUTURE

Model Number C0932191

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

If additional information becomes available a follow up report will be submitted.

Event Description

It was reported that there was an issue with dafilon suture.The client reported that the needle was detached from the thread when pulling out the suture from package.The defect was found prior to use, there is no patient involvement.

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market (b)(4) of this code-batch.There are no units in our stock.We have received two open and unused samples.The needle is attached to the thread and the suture is wound on the pack.We have tested the needle attachment strength of the samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 0.54 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.Needle attachment strength results before releasing the product were 0.51 kgf in average and 0.38 kgf in minimum and fulfilled ep requirements.Final conclusion: although the results of the 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.

• Brand Name: DAFILON BLUE 5/0 (1) 45CM DS19
• Type of Device: OTHER SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa, 121; rubí, 08191 ; SP 08191
• MDR Report Key: 10618693
• MDR Text Key: 209587640
• Report Number: 3003639970-2020-00357
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: K151165
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0932191
• Device Catalogue Number: C0932191
• Device Lot Number: 620116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1