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

Model Number C3090435

Device Problems Difficult to Open or Remove Packaging Material (2922); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

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

Event Date 11/22/2023

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 optilene suture.The client reported that the product is difficult to remove from the film, gets stuck from time to time and curls.Tears when removed from the foil / when knotting.This phenomenon has been noticeable for about 3-4 months.No further information has been received.

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 received a closed sample to analyze this complaint.Pull out of suture in the closed sample received is correct and the current one.Suture has been pulled out without difficult and does not become tangled.On the other hand, about curling defect, in the thread length we can see that there is the typical curve according to winding process of racepack plastic carrier.We have tested the knot pull tensile strength of the closed sample received and the result fulfils the requirements of the european pharmacopoeia (ep): 1.81 kgf (ep requirements: 0.92 kgf in average and 0.31 kgf in minimum) 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.Conclusion root cause analysis: it has not been possible to determine the root cause because the closed sample received complies the european pharmacopoeia and b.Braun surgical requirements.Final conclusion: final conclusion: although the results of the sample received fulfil the specifications of european pharmacopoeia/ b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.The case is considered not confirmed by evidence of the closed sample received.Corrective measures: 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: OPTILENE 3/0 (2) 45CM DS24 (M) RCP
• 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: 18353746
• MDR Text Key: 331192114
• Report Number: 3003639970-2023-00425
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K133890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C3090435
• Device Catalogue Number: C3090435
• Device Lot Number: 121215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• 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