MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. DAFILON BLUE 3/0 (2) 45CM DS24; OTHER SUTURE

Model Number C0932353

Device Problems Dull, Blunt (2407); Material Split, Cut or Torn (4008)

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

Event Date 12/11/2022

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 client reported that the needle blunts after 1 or 2 passes and also the thread breaks easily.

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed in the market 20,124 units.There are no units in stock in b.Braun surgical's warehouse.We have received 2 closed samples.We have tested the knot pull tensile strength of the closed samples received and the results fulfill the requirements of the european pharmacopoeia (ep): 2.26 kgf in average and 2.21 kgf in minimum (ep requirements: 0.92 kgf in average and 0.31 kgf in minimum).We have also tested the needle penetration performance (1st penetration) of the two needles received and the results does not fulfill b.Braun surgical requirements: 0.545 n in average and the maximum for the 1st penetration average is 0.480 n.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.Final conclusion: taking into account that the results of samples received do not fulfil the b.Braun surgical specifications regarding needle blunt defect, we conclude that the complaint is confirmed by evidence of the samples received.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 3/0 (2) 45CM DS24
• 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: 16082293
• MDR Text Key: 308395341
• Report Number: 3003639970-2022-00579
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/01/2023

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: C0932353
• Device Catalogue Number: C0932353
• Device Lot Number: 620356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2022
• Initial Date FDA Received: 01/02/2023
• Supplement Dates Manufacturer Received: 01/27/2023
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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