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

Model Number C0932205

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/02/2022

Event Type  malfunction  

Event Description

It was reported an issue with dafilon suture.The client reported that it was noticed that the needle and thread were broken and could not be used when preparing for the preoperative object and was replaced immediately.No additional information has been received.

Manufacturer Narrative

Analysis and results: there were no previous complaints of this code batch, three cases received the same day from two different end users.Two cases regarding missing component and another regarding needle detachment (the mfr report numbers of the other two cases received are:3003639970-2023-00342, 3003639970-2023-00343.We manufactured and distributed in the market 38,160 units of this code batch.There are no units in stock in b.Braun surgical's warehouse.We have not received any samples nor pictures showing the defect.Without closed and/or defective samples a proper analysis cannot be performed.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Needle attachment results before releasing the product were 1.16 kgf in average and 0.94 kgf in minimum and fulfilled the requirements of the european pharmacopoeia: 0.46 kgf in average and 0.23 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.

• 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, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer Contact: martina laporte ; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 17957175
• MDR Text Key: 326403746
• Report Number: 3003639970-2023-00344
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151165
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0932205
• Device Catalogue Number: C0932205
• Device Lot Number: 621454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• 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
• Patient Age: 71 YR
• Patient Sex: Male