MAUDE Adverse Event Report: B.BRAUN SURGICAL SA NOVOSYN VIOLET 1 (4) 90CM HS37S (M); SUTURES

Model Number C0068583

Device Problem Device Issue (2379)

Patient Problem Seroma (2069)

Event Date 01/30/2018

Event Type  malfunction  

Manufacturer Narrative

Samples received: two unopened pouches (to analyze (b)(4)).Analysis and results: there are no previous complaints of this code batch.We have received the same day 6 cases of seroma after surgery from the same hospital and three possible codes-batches involved.We manufactured and distributed in the market (b)(4) units of this code batch.There are no units in our stock.We have received two closed samples to analyze (b)(4).We have checked these samples and no defects have been found.Tightness test to the samples received has been performed and the units are tight.We have tested the knot pull tensile strength of the samples received and the results fulfil the requirements of the (b)(4): 6.45 kgf in average and 6.36 kgf in minimum (ep requirements: 5.18 kgf in average and 2.59 kgf in minimum).Furthermore, degradation test results conducted on the samples received fulfil b.Braun surgical requirements.In the degradation test, threads are introduced in a 0.9 % nacl solution at 37ºc for 14 days.After this period, the knot pull tensile strength of the thread is tested.The results for the samples received are 4.65 kgf in average and 4.46 kgf in minimum.B.Braun surgical requirement is 2.69 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.Sterilization process was also normal and the results of the sterilization control are correct.Novosyn biocompatibility has been tested in several experiments.In sensitization and irritation tests the harmlessness of novosyn was proved.Final conclusion: although the results of the samples received fulfil the specifications of (b)(4) / 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.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.

Event Description

Country of complaint: (b)(6).Seroma 2-3 days after surgery.

• Brand Name: NOVOSYN VIOLET 1 (4) 90CM HS37S (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: 7311086
• MDR Text Key: 101714659
• Report Number: 3003639970-2018-00111
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2022
• Device Model Number: C0068583
• Device Catalogue Number: C0068583
• Device Lot Number: 117114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Distributor Facility Aware Date: 02/05/2018
• Date Manufacturer Received: 02/05/2018
• 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