MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOMAX VIOLET 2/0 (3) 150CM HR26 (M); SUTURES

Model Number B0041444

Device Problem Break (1069)

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

Event Date 10/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country of complaint: (b)(6).Thread broken very easily.

Manufacturer Narrative

Samples received: 1 unopened and 1 open pouch.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 one closed sample and one open and used sample with the thread broken.Tightness test to the closed sample received has been performed and the unit is tight.We have tested the knot pull tensile strength of the closed sample received and the result fulfils the requirements of the european pharmacopoeia (ep): xi= 3.92 kgf (ep requirements: 2.73 kgf in average and 1.37 kgf in minimum).A minimum of five samples would be preferred because is the minimum number of units that requires the pharmacopoeia.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.Knot pull tensile strength results before releasing the product were 4.15 kgf in average and 3.90 kgf in minimum and fulfilled ep requirements.Remarks: when working with monomax® 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 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.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: MONOMAX VIOLET 2/0 (3) 150CM HR26 (M)
• 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, barcelona 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 7173639
• MDR Text Key: 96754065
• Report Number: 3003639970-2018-00020
• Device Sequence Number: 1
• Product Code: NWJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K100876
• 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: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2018
• Device Model Number: B0041444
• Device Catalogue Number: B0041444
• Device Lot Number: 113363V168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/22/2017
• Device Age: 4 YR
• Date Manufacturer Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2013
• 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