MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. OPTILENE 4/0 (1,5) 75CM 2XDR13 CV RCP; CARDIAC SUTURE

Model Number C3095908

Device Problem Material Twisted/Bent (2981)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was an issue with optilene suture.The client reported that the tip of the needle bends when it passes through tissue and vein.The type of surgery was prosthesis removal with subsequent implantation of a vein interposition.There was no patient harm and the outcome was good.No additional information has been provided.

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code batch of which we manufactured 252 units.There are 36 units in stock in b.Braun surgical's warehouse.We have received an open pack with a used needle.The needle has been visually analyzed and the tip of the needle is bent due to a needle holder.There are marks of it in the bending area.Bending strength test has been performed to the used needle and the result is 5.99 nxcm in minimum, fulfilling the specifications of the needle: 4.2 nxcm in minimum.Reviewed the batch manufacturing records of the needle batch, the results of the needle bending strength tests were 5.81 nxcm in minimum, fulfilling the specifications (4.2 nxcm in minimum).We conclude that the needle bending in the tip area is caused by a wrong handling of the needle, not according to 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 1/2 of the distance from the fibre attachment end to the needle point, never at the end where the fibre is attached or the needle point.) final conclusion: although the results of the samples 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 samples 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 2XDR13 CV RCP
• Type of Device: CARDIAC SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 10940535
• MDR Text Key: 219340197
• Report Number: 3003639970-2020-00451
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): Y
• PMA/PMN Number: K133890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

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: C3095908
• Device Catalogue Number: C3095908
• Device Lot Number: 119483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/03/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1