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

Model Number C0068047

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

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

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).During an operation, a suture used on the bowel broke before the end of the case.The suture did not break apart, but the knot did not hold.There were two lot numbers used, lot 113295 and 114055.

Manufacturer Narrative

Us reporting agent notified on (b)(4) 2014.Manufacturing site evaluation: samples rec'd: 3 unopened pouches.There are no previous complaints of this code/batch.There are no units in oem stock.All packs rec'd are tight.Tested the knot pull tensile strength of the samples rec'd and the results fulfil the requirements of the oem.Linear pull tensile strength results of the samples rec'd were tested and the results are correct and usual values for this thread and size.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil oem requirements.Final conclusion: the complaint is not corresponding (not justified).Actions on product: not applicable.Corrective/preventive actions: not applicable.

• Brand Name: NOVOSYN VIOLET 2/0 (3) 70CM HR30 (M)
• Type of Device: SYNTHETIC ANSORBABLE 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: 3960942
• MDR Text Key: 4560432
• Report Number: 2916714-2014-00374
• 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
• 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 Expiration Date: 01/01/2019
• Device Model Number: C0068047
• Device Catalogue Number: C0068047
• Device Lot Number: 114055
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: No
• 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