MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. DAFILON BLUE 4/0 (1.5) 75CM DS24; OTHER SUTURES

Model Number G0935344

Device Problem Dull, Blunt (2407)

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

Event Date 03/13/2024

Event Type  malfunction  

Manufacturer Narrative

Summary of investigation: 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 received 8 closed samples for analysis.We have checked the needles of the samples received and the tips, edges and geometry are within the specification.We have tested the needle penetration performance (average 1st penetration) of the 8 needles received and the results do not fulfill the specification.Needle penetration performance result (average 1st penetration) of needles tested of the raw material batch used in this product during production was 0.403 n and fulfilled the specification (<0.480 n).Batch manufacturing record: reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfilled usp/european pharmacopoeia and b.Braun surgical requirements.Conclusion root cause analysis: the root-cause could not be clearly identified by the needle manufacturer.A non-conformity report (inc cc/003/24) was opened to manage the final investigation and corresponding actions.Final conclusion: taking into account that the results of the samples received do not fulfil b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the samples received.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.

Event Description

It was reported an issue with dafilon suture.The client reported that two doctors complained that this suture needle gets blunt very quickly.Additional information has not been provided.

• Brand Name: DAFILON BLUE 4/0 (1.5) 75CM DS24
• 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: 19162147
• MDR Text Key: 340798581
• Report Number: 3003639970-2024-00142
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G0935344
• Device Catalogue Number: G0935344
• Device Lot Number: 623257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2023
• 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