MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. DAFILON BLUE 3/0 (2) 75CM DS19; NYLON SUTURE

Model Number C0935212

Device Problem Material Frayed (1262)

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

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Thread is fraying.

Manufacturer Narrative

Manufacturing site evaluation: there are no previous complaints of this code/batch.There are no units in oem stock.(b)(4) units of this code-batch were manufactured and distributed.Received 19 closed samples and 1 open sample with the thread detached from the needle (needle not returned).Visually, thread surface appearance of open and closed samples received is correct.No fraying has been found on any received samples.Sewing test on artificial skin tissue has been conducted with the sample received and fraying does not appear when pulling thread through the tissue.Visual appearance is as expected.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/preventative actions: not applicable.

• Brand Name: DAFILON BLUE 3/0 (2) 75CM DS19
• Type of Device: NYLON SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL S.A.; rubi (barcelona) ; SP
• Manufacturer (Section G): AESCULAP, INC.; 121 carretera de terrassa; rubi (barcelona) 0819 1; SP 08191
• Manufacturer Contact: michelle link ; 615 lambert pointe drive; hazelwwod, MO 63042 ; 3145515938
• MDR Report Key: 3829001
• MDR Text Key: 15111509
• Report Number: 2916714-2014-00345
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K990090
• 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: 05/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2018
• Device Model Number: C0935212
• Device Catalogue Number: C0935212
• Device Lot Number: 603462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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