MAUDE Adverse Event Report: B.BRAUN SURGICAL S.A NOVOSYN VIOLET 5/0 (1) 70CM HR17 (M); SYNTHETIC ABSORBABLE SUTURE

Model Number C0068012

Device Problems Product Quality Problem (1506); Out-Of-Box Failure (2311)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Complaint states: removing the needle and suture when open the packing.

Manufacturer Narrative

Us reporting agent notified on: (b)(4) 2014.Manufacturing site evaluation: evaluation is ongoing.

• Brand Name: NOVOSYN VIOLET 5/0 (1) 70CM HR17 (M)
• Type of Device: SYNTHETIC ABSORBABLE SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL S.A; rubi (barcelona) ; ES
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi (barcelona) 0819 1; ES 08191
• Manufacturer Contact: michelle link ; 615 lambert pointe dr; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 4077299
• MDR Text Key: 18575932
• Report Number: 2916714-2014-00675
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• PMA/PMN Number: K122734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Type of Report: Initial
• Report Date: 08/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2017
• Device Model Number: C0068012
• Device Catalogue Number: C0068012
• Device Lot Number: 112272
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2014
• 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