MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. DAFILON BLUE 5/0 (1) 45CM DS12; OTHER SUTURES

Model Number G0932078

Device Problems Dull, Blunt (2407); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

It was reported an issue with dafilon suture.The client reported that the needle is not sharp, hence, the doctor needs to put more effort to perform medical procedure.Additional information received: after inquiring with the customer, needle not sharp problem was found during therapy.Moreover, they found needle and thread detachment in some product pack as well (found in the same product box (same lot) and same day).Additional information has not been provided.

Manufacturer Narrative

Summary of investigation: there are no previous complaints of this code-batch.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 for analysis.Without any closed and/or defective sample we cannot carry out an analysis in order to take a decision.Regarding needle blunt defect, as stated in the instructions for use, care should be taken to avoid damaging the needle when using the suture material.Always grasp the needle in a section 1/3 to ½ of the distance from the fiber attachment end to the needle point, never at the end where the fibre is attached or the needle point.Grasping the needle at the area of its point could impair the penetration performance and cause a fracture of the needle.Grasping the needle close to the fibre attachment end could cause bending, breakage.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.The results of penetration performance test for each needle raw material batch used in this product during production were 0.296 n, 0.312 n and 0.357 n in average for the 1st penetration (needle specification of 0.360 n in maximum for the 1st penetration).Conclusion root cause analysis: it has not been possible to determine the root cause as no samples have been received.Final conclusion: 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 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 DS12
• Type of Device: OTHER SUTURES
• 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: 18695177
• MDR Text Key: 336511190
• Report Number: 3003639970-2024-00044
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G0932078
• Device Catalogue Number: G0932078
• Device Lot Number: 622365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2022
• 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: 28 YR
• Patient Sex: Female
• Patient Weight: 48 KG