MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOPLUS VIOLET 3/0 (2) 90CM 2XHR30 (M); SUTURES

Model Number C0024945

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).It was reported that due to the sutures there is still leakage.

Manufacturer Narrative

Samples received: 6 unopened pouches.Analysis and results: there are no previous complaints of the same batch.Manufactured and distributed in the market (b)(4) units of this batch.There are no units in stock.Tightness test to the samples received has been performed and all units are tight.We have tested the knot pull tensile strength of the samples received and the results fulfil requirements: the 2.36 kgf in average and 2.29 kgf in minimum (requirements: 1.81 kgf in average and 0.91 kgf in minimum) degradation test results conducted on the samples received fulfil b.Braun surgical (bbs) requirements.In the degradation test, threads are introduced in sörensen solution at 37ºc for 28 days.After this period, the knot pull tensile strength of the thread is tested.The results for the samples received are 1.63 kgf in average and 1.54 kgf in minimum (bbs requirements: 1.14 kgf in average and 0.76 kgf in minimum).The linear pull tensile strength of the thread has also been tested after this period (28 days in sörensen solution at 37ºc), and the results fulfill b.Braun surgical (bbs) requirement.The results for the samples received are 2.46 kgf in average and 2.23 kgf in minimum (bbs requirement: 1.33 kgf in minimum).Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil b.Braun surgical requirements.Remarks: when working with monoplus® suture material, great care should be taken in order to ensure that the surgical instruments used, such as forceps or needle holders do not cause any crushing or crimping damage to the suture material.According to the results of the samples tested and the batch manufacturing record review, the product complies with our specifications and also fulfill requirements.Therefore, we do not see any manufacturing fault or material defect that could have caused the incidence.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) 90CM 2XHR30 (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: 6440794
• MDR Text Key: 71098954
• Report Number: 3003639970-2017-00157
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2020
• Device Model Number: C0024945
• Device Catalogue Number: C0024945
• Device Lot Number: 115291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/20/2017
• Date Manufacturer Received: 02/28/2017
• 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