MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. MONOSYN UNDYED 3/0 (2) 70CM DS24 (M) RCP; SYNTHETIC ABSORBABLE MONOFILAR SUTURE

Model Number C2023215

Device Problem Dull, Blunt (2407)

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

Event Date 04/28/2023

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 monosyn suture.The client reported blunt needle.No further information has been received.

Manufacturer Narrative

Analysis and results: 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 stock in b.Braun surgical's warehouse.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, there are no incidences related to this issue and the results during the process fulfil usp/ep and b.Braun surgical requirements.Needle penetration performance (1st penetration) result of needles tested of each raw material batch used in this product during production were 0.400 n and 0.440 n in average and fulfilled the specification (<0.480 n).As stated in the instructions for use of the product, "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 fibber attachment end to the needle point, but never directly at the end where the fibber is attached or at the point of the needle.Grasping the needle at the area of the point could impair the penetration performance and cause a fracture of the needle.Grasping the needle close to the fibber attachment end could cause bending and breakage of the needle." 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.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: MONOSYN UNDYED 3/0 (2) 70CM DS24 (M) RCP
• Type of Device: SYNTHETIC ABSORBABLE MONOFILAR 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: 17008511
• MDR Text Key: 316023225
• Report Number: 3003639970-2023-00180
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K011375
• 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: 04/08/2023

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: C2023215
• Device Catalogue Number: C2023215
• Device Lot Number: 122375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2023
• Initial Date FDA Received: 05/26/2023
• Supplement Dates Manufacturer Received: 08/03/2023
• Supplement Dates FDA Received: 08/04/2023
• 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