MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. OPTILENE 4/0 (1,5) 75CM DSMP19 (M) RCP; NON-CARDIOVASCULAR SUTURE

Model Number C3090673

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 08/08/2022

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 optilene suture.The client reported that the labelling was missing on the outer box.

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code-batch or units in our stock.We manufactured and distributed in the market (b)(4) units of this code-batch.We have received a box that does not contain the front box label.This defect was caused in the warehouse when preparing the shipment.Upon checking traceability, it has been verified that this box was labelled.However, it is likely that it was peeled off for some reason and the personnel involved did not notice it.Therefore, the box was not discarded and consequently supplied to the customer by mistake.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.Considering that there are no previous complaints of this code-batch, we consider that this is an isolated an accidental box but whole batch is correct.Final conclusion: taking into account that the box received does not fulfil b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the failure in the box received.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: OPTILENE 4/0 (1,5) 75CM DSMP19 (M) RCP
• Type of Device: NON-CARDIOVASCULAR 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: 15368561
• MDR Text Key: 305386991
• Report Number: 3003639970-2022-00399
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C3090673
• Device Catalogue Number: C3090673
• Device Lot Number: 122153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2022
• 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