MAUDE Adverse Event Report: B.BRAUN SURGICAL SA NOVOSYN VIOLET 2/0 (3) 70CM HR26 (M); SUTURES

Model Number C0068042

Device Problem Knotted (1340)

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 was reported that the knot does not hold when tied.

Manufacturer Narrative

Samples received: 3 unopened pouches.Analysis and results: there are no previous complaints of the same batch.We manufactured and distributed in the market (b)(4) units of this batch.There are no units in our stock.We have received three closed samples.Tightness test to the samples received has been performed and the units are tight.We have tested the knot security control of the samples received and the results are 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 b.Braun surgical requirements.Final conclusion: although the results of the samples received fulfil 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.Anyway, you will receive a credit note for the units sent for analysis.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 HR26 (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: 6791669
• MDR Text Key: 82637124
• Report Number: 3003639970-2017-00422
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2020
• Device Model Number: C0068042
• Device Catalogue Number: C0068042
• Device Lot Number: 115467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/03/2017
• Date Manufacturer Received: 07/28/2017
• 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