MAUDE Adverse Event Report: B. BRAUN SURGICAL S. A. DAFILON BLUE 5/0 (1) 45CM DS19; SUTURE

Model Number C0932191

Device Problems Loss of or Failure to Bond (1068); Device Operates Differently Than Expected (2913)

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

Event Date 07/07/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Complaint states: thread keeps falling off needle.

Manufacturer Narrative

Us reporting agent notified on: (b)(6) 2014.Manufacturing site evaluation: samples received: 23 unopened pouches.There are no previous complaints of this code/batch.There are no units in oem stock.We have tested the needle attachment of the closed samples received and the results fulfill the requirements of the oem.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).

• Brand Name: DAFILON BLUE 5/0 (1) 45CM DS19
• Type of Device: 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 0819 1; SP 08191
• Manufacturer Contact: michelle link ; 615 lambert pointe dr.; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 4047683
• MDR Text Key: 4810811
• Report Number: 2916714-2014-00641
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K990090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2018
• Device Model Number: C0932191
• Device Catalogue Number: C0932191
• Device Lot Number: 613361
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2014
• 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