MAUDE Adverse Event Report: B BRAUN SURGICAL SA MONOMAX VIOLET 1 (4) 200CM HR48 LOOP(M); SYNTHETIC ABSORBABLE MONOFILAR

Model Number B0041325

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional "the surgeon was performing a hysterectomy on a patient who has had 3 multiparous and has ca grade 3.During the procedure while performing the second knotting the suture broke, causing a delay in surgery when the surgeon had to complete the surgery with another suture." additional patient information and verify delay time of surgery has been requested.When additional information is received a follow up report will be submitted.

Manufacturer Narrative

Analysis and results: there are no previous complaints of the same code-batch.We have received one closed sample to analyze this complaint.Tightness test to the sample received has been performed and the unit is tight.We have tested the knot pull tensile strength of the sample received and the result fulfils the requirements of the european pharmacopoeia (ep): xi= 5.92 kgf (ep requirements: 5.18 kgf in average and 2.59 kgf in minimum).Additionally, we have tested the knot security control of the sample received and the result is into the current range for this thread and size.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfilled usp/ep and b.Braun surgical 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 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.

• Brand Name: MONOMAX VIOLET 1 (4) 200CM HR48 LOOP(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: 8182168
• MDR Text Key: 131339129
• Report Number: 3003639970-2018-00799
• Device Sequence Number: 1
• Product Code: NWJ
• Combination Product (y/n): N
• PMA/PMN Number: K100876
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B0041325
• Device Catalogue Number: B0041325
• Device Lot Number: 117411
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/17/2019
• Date Manufacturer Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1