MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. OPTILENE 5/0 (1) 75CM HR13 CV RCP; CARDIAC SUTURE

Model Number C3090500

Device Problem Insufficient Information (3190)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 02/28/2023

Event Type  Injury  

Event Description

It was reported an issue with optilene suture.The client reported that when closing the dura mater, the optilene 4/0 and 5/0 cut thru and dura tear.The patients were mainly pediatric, between neonatal and 18 years old; between 6-40 kg.Three knots were made and continuous suture was done.It occurred during surgery and also one week after surgery.The surgery performed was spina bifida, chiari malformation and there was prolongation for more than 15 minutes.The patient's outcome was: csf leakage - cerebrospinal fluid.However, it has also been reported that there were no injuries to the patient.The mfr report number for the other suture (optilene 4/0) is: 3003639970-2023-00101.

Manufacturer Narrative

If additional information becomes available a follow up report will be submitted.

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code batch.(b)(4) units of this code batch were manufactured and distributed in the market.There are no units in stock in b.Braun surgical's warehouse.We have received 1 closed sample to analyze this case.Sewing test on artificial skin tissue has been conducted with the closed sample received and thread damaged/splitting does not appear when pulling the thread through the tissue.Visual appearance is the usual one before and after sewing test.We have tested the knot pull tensile strength of the closed sample received and the result fulfilled the requirements of the european pharmacopoeia (ep): 0.84 kgf in average and in minimum (ep requirements: 0.31 kgf in average and 0.10 kgf in minimum).We have also tested the needle attachment strength of the closed sample received to discard a faulty needle-attachment during manufacturing process that could cause splitting in the thread and the results fulfilled the requirements of the european pharmacopoeia (ep): 0.65 kgf in average and in minimum (ep requirements: 0.23 kgf in average and 0.11 kgf in minimum).No splitting has been found.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.We have also reviewed the complaint history record, and there are no previous complaints in any of the products manufactured with the same thread raw material batches as the used in this product.As indicated in the instructions for use of the product, when working with optilene suture material, great care should be taken to avoid any crushing or crimping damage of the monofilament by instruments such as forceps or needle holders.According to the results of the tests realized to the closed sample received from the customer and the batch manufacturing records review, the product complies with our specifications; therefore, we do not see any manufacturing fault or material defect that could have caused the incidence.Final conclusion: although the results of the closed 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.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 5/0 (1) 75CM HR13 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: 16608591
• MDR Text Key: 312008412
• Report Number: 3003639970-2023-00102
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C3090500
• Device Catalogue Number: C3090500
• Device Lot Number: 122054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2023
• 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
• Patient Outcome(s): Other