MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOPLUS VIOLET 4/0 (1.5) 70CM HR17 (M); SUTURES

Model Number C0024014

Device Problem Failure To Adhere Or Bond (1031)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 32 unopened pouches.Analysis and results: there are no previous complaints of this code batch.(b)(4) units were manufactured and distributed of this code batch, there are (b)(4) units in our 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 monosyn® suture materials great care should be taken to ensure that the use of surgical instruments, such as tweezers and needle holders, does not cause the material to be damaged by being pinched or kinked".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.The customer will receive a credit note for one box of product as a quality courtesy.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).The thread which is complained is used to make the stitch around and through vessels.The thread is broken even before knotting, while pulling it through the depth.The professor has tried it several times, then he switched the batches.Threads from 2 batches had the same behaviour.

• Brand Name: MONOPLUS VIOLET 4/0 (1.5) 70CM HR17 (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: 5608910
• MDR Text Key: 43666598
• Report Number: 2916714-2016-00325
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K031216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Model Number: C0024014
• Device Catalogue Number: C0024014
• Device Lot Number: 116036V004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2016
• Distributor Facility Aware Date: 04/21/2016
• Date Manufacturer Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2016
• 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