MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOMAX VIOLET 0 (3,5) 150CM HR37S(M)DDP; SUTURES

Model Number B0041043

Device Problem Break (1069)

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

Event Date 02/24/2016

Event Type  malfunction  

Manufacturer Narrative

Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or any other technological characteristics with a medical device registered within the u.S.(b)(4).Manufacturing site evaluation: samples received: 10 unopened pouches.Analysis and results: there are no previous complaints of this code batch, there are no units in stock.Tightness test to the sample received has been performed and the unit is tight.Tested the knot pull tensile strength of the sample received and the results fulfills the oem requirements.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfills the oem requirements.As instructed for use: "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: complaint is not justified.Results of the samples received fulfills the oem requirements.Note is taken of this incidence in order to assess if new or additional actions are needed.Actions on product: based on the conclusion derived from investigation, it is not required to take an action on distributed product.A credit note for one box of product as a quality courtesy will be issued.Corrective/preventive actions: according to the internal procedures, there is no need to establish corrective or preventive actions.This complaint is recorded for trending analysis to assess if actions are needed in the future.

Event Description

Country of complaint: (b)(6).Thread broken several times very easily.Customer change to another batch and have no problems with the thread.

• Brand Name: MONOMAX VIOLET 0 (3,5) 150CM HR37S(M)DDP
• 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: 5533411
• MDR Text Key: 41424614
• Report Number: 2916714-2016-00217
• Device Sequence Number: 1
• Product Code: NWJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 03/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2020
• Device Model Number: B0041043
• Device Catalogue Number: B0041043
• Device Lot Number: 115255V004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2016
• Distributor Facility Aware Date: 03/17/2016
• Date Manufacturer Received: 03/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2015
• 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