MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. OPTILENE 2/0 (3) 75CM HR26 CV RCP; CARDIAC SUTURE

Model Number C3090042

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

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 2,772 units.There are no units in our stock.We have received an open box labelled with the code-batch c3090042-123292 (optilene 2/0 (3) 75cm hr26) that contains 36 unopened race-packs of the code-batch 3090170-123291 (optilene 1 (4) 75cm hr48).Upon internal investigation, it has been determined that this mix-up took place in manufacturing area when conditioning the product.Both products were packed one after the other the same day in manufacturing line.We assume that the operation of clean line was not performed correctly and one box that contains optilene code 3090170 was labelled as optilene code c3090042.As no other customer complaints have been received concerning this issue for this reference-batch, it has been determined that the mix-up was the one informed by the customer, assuming an isolated box.The personnel involved have been informed of this incidence.Batch manufacturing record: reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill usp/european pharmacopoeia and b.Braun surgical requirements.Conclusion root cause analysis: the most likely root cause determined is that the clean line operation between the two manufacturing orders during the product conditioning in the manufacturing line was not performed correctly.Final conclusion: taking into account that the product 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.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 optilene suture packaging.The client reported that in a box labelled as optilene usp 2/0 thread and hr26 needle (model number: c3090042), the suture packages inside are of optilene usp 1 thread and hr48 needle (model number: c3090170).There has been no damage to the patient, as the reference was not the one requested, it has not been used.No further information has been received.

• Brand Name: OPTILENE 2/0 (3) 75CM HR26 CV RCP
• Type of Device: CARDIAC 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: 18795640
• MDR Text Key: 337549552
• Report Number: 3003639970-2024-00074
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C3090042
• Device Catalogue Number: C3090042
• Device Lot Number: 123292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2023
• 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