MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. NOVOSYN VIOLET 3/0 (2) 12X45CM; SYNTHETIC ABSORBABLE SUTURE

Model Number C0058665

Device Problem Battery charger, defective (1054)

Patient Problem Not Applicable (3189)

Event Date 05/02/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Inner foil was welded with outer foil.

Manufacturer Narrative

Mfg site eval: eval on-going at mfg site.

• Brand Name: NOVOSYN VIOLET 3/0 (2) 12X45CM
• Type of Device: SYNTHETIC ABSORBABLE SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL S.A.; rubi (barcelona), es 0819 1; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL SA; 121 carretera de terrassa; rubi (bercelona), es 0819 1; GM 08191
• Manufacturer Contact: michelle link ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145513938
• MDR Report Key: 3880619
• MDR Text Key: 4508952
• Report Number: 2916714-2014-00407
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: C0058665
• Device Catalogue Number: C0058665
• Device Lot Number: 114115V004
• Date Manufacturer Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2014
• 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