MAUDE Adverse Event Report: B.BRAUN SURGICAL SA NOVOSYN VIOLET 2/0 (3) 70CM HR22 (M); SUTURES

Model Number C0068031

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 01/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 3 unopened and 1 open pouches.Analysis and results: there are no previous complaints of this code batch.Manufactured and distributed (b)(4) units of this code batch.There are no units in stock.There were three closed samples received and one open and unused sample with two sutures inside the first pack as can be see in enclosed picture.This defect could have been caused by the automatic winding machine during the manufacturing process.The machine took two sutures instead of one in the winding step.All closed samples received were checked and all are the correct ones.The three closed samples have one suture inside.Taking into account that no other complaints have been received concerning this issue for this code batch, and the closed samples have only one suture inside, this is considered an isolated unit, but the rest of units of the affected batch are correct.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: this complaint will be included in the analysis of trending, and corrective action will be open if applies.

Event Description

Country of complaint: (b)(6).It was reported that there were two sutures in the package instead of one.

• Brand Name: NOVOSYN VIOLET 2/0 (3) 70CM HR22 (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: 6348930
• MDR Text Key: 68152688
• Report Number: 3003639970-2017-00062
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 02/21/2017

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: 11/23/2020
• Device Model Number: C0068031
• Device Catalogue Number: C0068031
• Device Lot Number: 115481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Distributor Facility Aware Date: 01/27/2017
• Initial Date Manufacturer Received: 01/23/2017
• Initial Date FDA Received: 02/22/2017
• 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