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

Model Number C0068047

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 68 unopened and 1 open pouches.Analysis and results: there are no previous complaints of this code batch.(b)(4) units of this code batch were manufactured and distributed in the market, there are no units in stock.All closed pouches have been received and all had one suture inside.The open sample received has been checked and there are visible marks of two needles inside the first pack.This defect could have been caused by the automatic winding machine, it took two sutures instead of one in the winding step.Taking into account that no other complaints have been received concerning this issue for this code batch, this is considered an isolated unit.Final conclusion: taking into account that the results of the open sample received does not fulfill the oem specifications, the complaint is justified.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).It was reported that there were two needles in a packet.

• 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, 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: 6230977
• MDR Text Key: 64128997
• Report Number: 3003639970-2017-00006
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2021
• Device Model Number: C0068047
• Device Catalogue Number: C0068047
• Device Lot Number: 116302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Distributor Facility Aware Date: 12/21/2016
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 01/06/2017
• 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