MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. DAFILON BLUE 4/0 (1.5) 75CM DS19; OTHER SUTURE

Model Number C0935204

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/13/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported an issue with dafilon suture.The customer reported that during surgery, the thread is detached close to the needle.No further information received.

Manufacturer Narrative

Summary of investigation: there are two previous complaints of this code-batch, one of them regarding the same issue (closed as not confirmed after analysis).We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in our stock.We have not received any sample, only a picture of an open sample.However, without closed samples and/or defective samples a proper analysis cannot be performed.Batch manufacturing record: 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.Conclusion root cause analysis: it has not been possible to determine the root cause as no samples are received.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.Corrective measures: actions on distributed product 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) 75CM 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: 18235890
• MDR Text Key: 329319860
• Report Number: 3003639970-2023-00419
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K151165
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

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: C0935204
• Device Catalogue Number: C0935204
• Device Lot Number: 622366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 48 YR
• Patient Sex: Female