MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. NOVOSYN VIOLET 2/0 (3) 70CM HR30 (M); SYNTHETIC ABSORBABLE SUTURE

Model Number C0068047

Device Problems Battery charger, defective (1054); Break (1069)

Patient Problem Wound Dehiscence (1154)

Event Date 03/08/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Dehiscence of a wound ona child where it appears that a suture has snapped.The patient had to undergo further surgery plus experienced the trauma of having an open wound.

Manufacturer Narrative

Us reporting agent notified on (b)(4) 2014.Manufacturing site evaluation; samples received: 1 open pouch.We have received 1 open sample (without pack or information about batch number) with the thread broken.No batch number provided therefore unable to obtain information regarding previous complaints of the code/batch or if there are units in oem stock.The batch manufacturing record cannot be reviewed.Without any closed sample and article batch number, we cannot carry out a proper analysis.Final conclusion: the complaint is not corresponding (not justified).Actions on product: not applicable.Corrective/preventative actions: not applicable.

• Brand Name: NOVOSYN VIOLET 2/0 (3) 70CM HR30 (M)
• Type of Device: SYNTHETIC ABSORBABLE SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL S.A.; rubi (barcelona) 0819 1; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL SA; 121 carretera de terrassa; rubi (barcelona) 0819 1; SP 08191
• Manufacturer Contact: michelle link ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 3960953
• MDR Text Key: 16558582
• Report Number: 2916714-2014-00380
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 05/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0068047
• Device Catalogue Number: C068047
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2014
• 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