MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOPLUS VIOLET 3/0 (2) 70CM HR26 (M); SUTURES

Model Number C0024025

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that the thread broke during surgery.

Manufacturer Narrative

Samples received: 5 unopened and 1 open pouches.Analysis and results: there are no previous complaints of this batch of which (b)(4) units were manufactured and distributed in the market, there are no units in stock.Received five closed samples and one open unit with the needle detached from the thread and the tread still wound on the pack.In consequence needle attachment strength will be analyzed too as well as knot pull tensile strength.Tightness test to the closed samples received has been performed and the units are tight.Tested the knot pull tensile strength of the closed samples received and the results fulfill requirements: 2.32 kgf in average and 1.93 kgf in minimum (1.81 kgf in average and 0.91 kgf in minimum).Tested the needle attachment strength of the closed samples received and the results fulfill requirements: 2.49 kgf in average and 1.30 kgf in minimum (0.69 kgf in average and 0.35 kgf in minimum).Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill b.Braun surgical requirements.Knot pull tensile strength values before releasing the product were 2.37 kgf in average and 2.21 kgf in minimum, fulfilling requirements.Needle attachment strength values before releasing the product were 2.57 kgf in average and 0.75 kgf in minimum, fulfilling also requirements.Final conclusion: although the results of the samples received fulfil the specifications of b.Braun surgical, 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.

• Brand Name: MONOPLUS VIOLET 3/0 (2) 70CM HR26 (M)
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6422036
• MDR Text Key: 70520660
• Report Number: 3003639970-2017-00141
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K031216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0024025
• Device Catalogue Number: C0024025
• Device Lot Number: 116265
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/13/2017
• Date Manufacturer Received: 02/23/2017
• 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