MAUDE Adverse Event Report: B BRAUN SURGICAL SA OPTILENE 5/0 (1) 75CM 2XDR13 CV RCP; SUTURES

Model Number C3095907

Device Problems Material Frayed (1262); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Samples received: 3 unopened racepacks.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.We have received three closed samples.We have tested the knot pull tensile strength of the samples received and the results fulfill the requirements of the european pharmacopoeia (ep): (b)(4) in average and (b)(4) in minimum (ep requirements: (b)(4) in average and (b)(4) in minimum).Additionally, needle attachment strength test has been conducted on the closed samples received in order to discard a faulty needle attachment during manufacturing process that could cause splitting/fraying in the thread.The needle attachment strength results fulfil the requirements of the european pharmacopoeia (ep): (b)(4) in average and (b)(4) in minimum (ep requirements: (b)(4) in average and (b)(4) in minimum).We have not found splitting on thread surface on the closed samples received before and after performing tests.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.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.Final conclusion: although the results of the closed 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.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 by the healthcare professional "thread frayed and spliced after long procedure.Vessel surgery / hernia -> fit a patch with 30 stitches." no patient injury, outcome of patient good.No delay in surgery reported.

• Brand Name: OPTILENE 5/0 (1) 75CM 2XDR13 CV RCP
• Type of Device: SUTURES
• Manufacturer (Section D): B BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer (Section G): B BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 8470243
• MDR Text Key: 140509532
• Report Number: 3003639970-2019-00336
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2019

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 Expiration Date: 06/29/2023
• Device Model Number: C3095907
• Device Catalogue Number: C3095907
• Device Lot Number: 118265V004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/25/2019
• Device Age: 7 MO
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1