MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. DAFILON BLUE 4/0 (1.5) 45CM DS19; OTHER SUTURE

Model Number C0933201

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

The lot number involved is unknown.The possible lot numbers are the following: 619095, 619281, 619382, 619426, 619501, 620043 or 620106.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.It occurred between three or four times.Additional information has not been provided.

Manufacturer Narrative

Analysis and results: the involved batch number of the dafilon reference involved c0933201 is unknown.The possible batches are: 619095, 619281, 619382, 619426, 619501, 620043 and 620106.We manufactured (b)(4) units of the batch 619095, (b)(4) units of batch 619281, (b)(4) of batch 619382, (b)(4) units of batch 619426, (b)(4) units of the batch 619501, (b)(4) units of batch 620043 and (b)(4) units of batch 620106.There are in stock 60 units of batch 619095 and 12 units of batch 619501 and (b)(4) units of the batch 620043.There are no units in stock of the other possible batches 619281, 619381, 619426 or 620106.We have not received any sample from the customer.However, we have received from stock 12 unopened pouches of each of the following batches to analyze this complaint: 619095, 619501 and 620043.We have tested the needle attachment strength of the samples received from stock and the results fulfil the requirements of the european pharmacopoeia (ep requirements: 0.46 kgf in average and 0.23 kgf in minimum): batch 619095: 0.85 kgf in average and 0.64 kgf in minimum batch 619501: 0.91 kgf in average and 0.68 kgf in minimum batch 620043: 0.76 kgf in average and 0.71 kgf in minimum.In regards to the other possible batches (619281, 619382, 619426, 620106), without any sample we cannot carry out an analysis in order to take a decision.Reviewed the batch manufacturing record, these possible products 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 of batches 619095, 619501 and 620043 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.On the other hand, without samples of the batches 619281, 619382, 619426 and 620106, we are not in position of studying if the possible affected products do not fulfil the specifications.In consequence, a proper analysis cannot be done and the case is not confirmed due to lack of evidence.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 4/0 (1.5) 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: 10539687
• MDR Text Key: 207126946
• Report Number: 3003639970-2020-00332
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0933201
• Device Catalogue Number: C0933201
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1