MAUDE Adverse Event Report: B.BRAUN SURGICAL SA DAFILON BLUE 5/0 (1) 45CM DS16; OTHER SUTURE

Model Number C0932124

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

K990090.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.Additional information / investigation results will be provided in a supplemental report, if applicable.

Event Description

It was reported that there was an issue with dafilon blue suture.The customer reported that the thread detached from the needle.No further information is available.

Manufacturer Narrative

Investigation: samples received: there are no samples available for analysis.Analysis and results: there are no previous complaints of this code-batch.We manufactured and mostly distributed in the market (b)(4) units of this code-batch.There were (b)(4) units in stock that were requested for analysis.Without any sample we cannot carry out an analysis in order to take a decision.Nevertheless, we have tested the needle attachment strength of the samples received from stock and the results fulfil the requirements of the european pharmacopoeia (ep): 0.69 kgf in average and 0.38 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.Final conclusion: although the results of the samples received from stock 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.No corrective/preventive actions needed.

• Brand Name: DAFILON BLUE 5/0 (1) 45CM DS16
• Type of Device: OTHER SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 9682355
• MDR Text Key: 178218936
• Report Number: 3003639970-2020-00081
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• 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: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0932124
• Device Catalogue Number: C0932124
• Device Lot Number: 619152
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1