MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOMAX VIOLET 1(4)150CM HRT48 LOOP(M; SYNTHETIC ABSORBABLE MONOFILAR

Model Number B0041222

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

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.K100876.Investigation: samples received: (b)(4) closed samples.Analysis and results: there are no previous complaints of this code batch.We have manufactured and distributed in the market (b)(4) units of this code batch.There are no units in our stock.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):5.86 kgf in average and 4.80 kgf in minimum (ep requirements: 5.18 kgf in average and 2.59 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.Remarks: as indicated in the instructions for use of the product: "when working with monomax® suture materials great care should be taken to ensure that the use of surgical instruments, such as forceps and needle holders, do not cause any crushing or crimping damage to the suture material".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.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.No corrective/preventive actions needed.

Event Description

It was reported the thread broke intra-operatively.The reporter indicated that the thread (suture) broke during suturing in two different surgical procedures (two different patients) during closure of the abdomen.The operating room personnel has been using monomax for a long time and when trying to reproduce the problem in presence of the sales rep, no problem could be detected.Additional information has been requested, however, not yet received.This report is for the second patient.

• Brand Name: MONOMAX VIOLET 1(4)150CM HRT48 LOOP(M
• Type of Device: SYNTHETIC ABSORBABLE MONOFILAR
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer (Section G): B/ BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer Contact: lindsay chromiak ; 3773 corporate parkway; center valley, PA 18034 ; 8002581946
• MDR Report Key: 8668583
• MDR Text Key: 147194398
• Report Number: 3003639970-2019-00454
• Device Sequence Number: 1
• Product Code: NWJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2023
• Device Model Number: B0041222
• Device Catalogue Number: B0041222
• Device Lot Number: 118516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/22/2019
• Date Manufacturer Received: 05/08/2019
• 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