MAUDE Adverse Event Report: B.BRAUN SURGICAL SA NOVOSYN VIOLET 2/0 (3) 70CM HR30 (M); SUTURES

Model Number C0068047

Device Problems Degraded (1153); Naturally Worn (2988)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(6) is submitting this report on behalf of b.Braun surgical s.A.(manufacturer).Exemption number: (b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).For 6 patients, defect of resorption of the thread with opening of several scars in a second time and an infection of the material.

Manufacturer Narrative

Samples received: none.Analysis and results: batch number/s involved were not known.We have checked the batch manufacturing records of the batches supplied to the customer in the previous 12 months of the incidents.There are no units in stock of any of the possible batches.Moreover, there are no previous complaints of any of the possible batches.Reviewed the batch manufacturing records, one of the batches has an incidence, they all were released into the market fulfilling b.Braun surgical requirements.Mode of action: suture materials are used primarily for adaptation of the wound edges to render possible and undisturbed wound healing.Upon implantation of novosyn sutures a mild inflammatory reaction may occur, which is typical of an endogenous reaction to foreign bodies.As time passes, the suture material is encapsulated by fibrous connective tissue.Novosyn is metabolized to glycolic acid and lactic acid by hydrolysis without causing any enduring alterations of the implantation site.About 75% of the original tensile strength remains after 14 days of implantation, about 40-50% after 21 days and about 25% after 28 days.The complete mass absorption of novosyn takes place at 56-70 days, when the tissue is normally perfused.Contra-indications: novosyn suture materials are contra-indicated for applications where prolonged support of the wound closure by the suture material is required (e.G.Cardio-vascular surgery).Notes / warnings / precautionary measures: users should be familiar with the surgical procedures and techniques involving absorbable sutures when using novosyn.The risk of wound dehiscence may vary depending upon the site of application and the type of material used.Acceptable surgical practice should be followed for the management of contaminated or infected wounds.Skin sutures which remain in place longer than 7 days may cause localized irritation and should be snipped off or removed as indicated.Consideration should be taken in the use of absorbable sutures in tissues with poor blood supply as suture extrusion and delayed absorption may occur.Subcuticular sutures should be placed as deeply as possible to minimize the erythema and induration normally associated with the absorption process.Side effects: as for every other suture material, prolonged contact with salt solutions such as urine and bile can lead to lithiasis.The following side effects may be associated with the use of this product: transitory local irritation, transient inflammatory foreign body reaction, enhanced bacterial infectivity, wound dehiscence and granulation.B.Braun proposes some tests with novosyn quick, which degrades faster.Novosyn quick in vitro studies show that 5 days post-implantation approximately 50% of the initial tensile strength remains.All of the original tensile strength is lost by approximately at 10-14 days post-implantation.The absorption of novosyn quick takes place after approximately 42 days.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: NOVOSYN VIOLET 2/0 (3) 70CM HR30 (M)
• Type of Device: SUTURES
• 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, barcelona 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6882835
• MDR Text Key: 87307561
• Report Number: 3003639970-2017-00467
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122734
• 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: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0068047
• Device Catalogue Number: C0068047
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/15/2017
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other