MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOPLUS VIOLET 4/0 (1.5) 70CM DS24 (M); SYNTHETIC ABSORBABLE MONOFILAR

Model Number C0024541

Device Problems Break (1069); Material Integrity Problem (2978)

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

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.K031216.If additional information becomes available a follow up report will be submitted.

Event Description

It was reported that the suture breaks off easily during use.The reporter indicated the thread broke during surgery.Patient information is not available.

Manufacturer Narrative

Samples received: (b)(4) unopened pouches.Analysis and results: there are no previous complaints of this code batch.There are no units in stock in b.Braun surgical's warehouse.We have received (b)(4) closed units.Tightness test to the closed samples received has been performed and the units are tight.We have tested the knot pull tensile strength of the closed samples received and the results fulfill the requirements of the european pharmacopoeia (ep): 1.71 kgf in average and 1.49 kgf in minimum (ep requirements: 0.97 kgf in average and 0.49 kgf in minimum).Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Final conclusion: although the results of the samples 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.The case is considered not confirmed by evidence of the samples received.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.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 4/0 (1.5) 70CM DS24 (M)
• Type of Device: SYNTHETIC ABSORBABLE MONOFILAR
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 9531576
• MDR Text Key: 173097508
• Report Number: 3003639970-2019-00929
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0024541
• Device Catalogue Number: C0024541
• Device Lot Number: 118432
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1