MAUDE Adverse Event Report: B BRAUN SURGICAL SA OPTILENE 4/0 (1,5) 90CM 2XHR26 CV RCP; SUTURE

Model Number C3090907

Device Problems Material Separation (1562); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation on-going.Supplemental report will be provided when additional information is available.

Event Description

It was reported that the suture thread spontaneously breaks.The frequency was unknown.The breakage occurs prior to use.Product was not used on a patient.

Manufacturer Narrative

Analysis and results: 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.Five closed samples were received.A knot pull tensile strength test was performed of the samples received and the results fulfil the requirements of the european pharmacopoeia (ep):1.30 kgf in average and 1.25 kgf in minimum (ep requirements: 0.51 kgf in average and 0.15 kgf in minimum).A review of the batch manufacturing record reveals this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.Remarks: 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.Final conclusion: although the results of the samples received fulfill 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.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.No corrective/preventive actions are needed.

• Brand Name: OPTILENE 4/0 (1,5) 90CM 2XHR26 CV RCP
• Type of Device: SUTURE
• Manufacturer (Section D): B BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 8164406
• MDR Text Key: 130342435
• Report Number: 3003639970-2018-00781
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• PMA/PMN Number: K133890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2023
• Device Model Number: C3090907
• Device Catalogue Number: C3090907
• Device Lot Number: 118254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Distributor Facility Aware Date: 12/12/2018
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1