MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. DAFILON BLUE 3/0 (2) 45CM DS19; OTHER SUTURE

Model Number C0932213

Device Problems Dull, Blunt (2407); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 05/13/2023

Event Type  malfunction  

Event Description

It was reported an issue with dafilon suture.The client reported that suture threads usp 3/0 and 4/0, sent as a replacement for other threads previously in use, are by no means ideal substitutes as they have needles that do not pierce the skin unless using incorrect force and methodical not correct.The threads are not superimposable in terms of quality, memory, smoothness to the corresponding ones from other companies.The thickness also does not match the 3/0 and 4/0 sizes.Related file: (b)(4).Additional information has been requested.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code-batch of which we manufactured and distributed in the market (b)(4) units.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.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfilled usp/ep and b.Braun surgical requirements.Needle penetration strength results conducted on samples tested during production of each needle raw material batch used in this product were 0.412n, 0.407n, 0.415n, 0.384n, 0.404n, 0.391n, 0.395n and 0.416n in average and fulfilled specifications: < 0.480n in average.These needles controlled during the control production have conforming penetration performance.Also, thread diameter results conducted on samples tested during production of the thread raw material batch used in this product were 0.220 mm in minimum and 0.230 mm in maximum and fulfilled specification: 0.200-0.249 mm.These values are in the usual range for this thread and size.Reviewed the complaint history records, there are no previous complaints in any of the products manufactured with the same needle raw material batches used in this product regarding needle blunt/deficient punction.There are also no previous complaints in any of the products manufactured with the same thread raw material batch used in this product regarding thread thickness issues.Remarks: 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.Reshaping needles should be avoided and may result in a loss of their strength and resistance towards bending and breaking.According to the batch manufacturing record review, the product complies with our specifications; therefore, we do not see any manufacturing fault or material defect that could have caused the incidence.Nevertheless, we take note of this incidence in order to assess if new or additional actions are needed.In addition, if any sample or additional information is received in the future, we will re-open the case and analyse it.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.Please note that when no samples are received our analysis is very limited.We regret any inconvenience this issue may have caused and thank you for your collaboration.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 3/0 (2) 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: 17057817
• MDR Text Key: 316607478
• Report Number: 3003639970-2023-00184
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 06/16/2023

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: C0932213
• Device Catalogue Number: C0932213
• Device Lot Number: 622305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2023
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: 05/26/2023
• Supplement Dates FDA Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2022
• 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: 55 YR