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

Model Number B0041222

Device Problem Break (1069)

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 is reported that the thread breaks during knotting.

Manufacturer Narrative

Samples received: 1 unopened pouch.Analysis and results: there are no previous complaints of this batch.Manufactured and distributed (b)(4) units of this batch.There are no units in stock.Received one closed sample.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.Xi= 7.19 kgf (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 fulfil 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.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 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: MONOMAX VIOLET 1(4)150CM HRT48 LOOP(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: 6415195
• MDR Text Key: 70517275
• Report Number: 3003639970-2017-00149
• Device Sequence Number: 1
• Product Code: NWJ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K100876
• 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: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2021
• Device Model Number: B0041222
• Device Catalogue Number: B0041222
• Device Lot Number: 116412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/13/2017
• Date Manufacturer Received: 02/16/2017
• 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