MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. NOVOSYN VIOLET 3/0 6X45CM; SYNTHETIC ABSORBABLE SUTURE

Model Number C0058645

Device Problem Battery charger, defective (1054)

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

Event Date 04/09/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Thread breaks easily.

Manufacturer Narrative

Us reporting agent notified on: (b)(4) 2014.Manufacturing site evaluation: samples received: 128 unopened pouches.There are no previous complaints of this code/batch.There are (b)(4) units in oem stock.All packs received are tight.Tested the knot pull tensile strength of the samples received and the results fulfill the requirements of the oem.Knot pull tensile strength results before releasing the product fulfilled oem requirements.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 3/0 6X45CM
• 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 S.A.; 121 carretera de terrassa; rubi (barcelona) ; SP
• Manufacturer Contact: michelle link ; 615 lambert pointe dr.; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 3877244
• MDR Text Key: 18368730
• Report Number: 2916714-2014-00368
• 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: 05/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2014
• 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: C0058645
• Device Catalogue Number: C0058645
• Device Lot Number: 114015V004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2014
• 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