MAUDE Adverse Event Report: B. BRAUN SURGICAL S. A. DAFILON BLUE 3/0 (2) 45CM DS19; NYLON SUTURE

Model Number C0933210

Device Problem Detachment Of Device Component (1104)

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

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Needle detachment.

Manufacturer Narrative

Us reporting agent notified on: (b)(4) 2014.Mfg site eval: samples received: 5 unopened and 1 open pouch (needle only, no thread).There are no previous complaints of this code/batch.There are no units in oem stock.Tested the needle attachment of the closed samples received and one of the samples did not meet oem requirements.Reviewed the batch mfg record, this product had a normal process and the results during the process fulfilled oem requirements.Final conclusion: the complaint is corresponding (justified).Corrective/preventive actions: oem has opened a corrective action in order to avoid this kind of incident in the future.

• Brand Name: DAFILON BLUE 3/0 (2) 45CM DS19
• Type of Device: NYLON 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; center valley PA 18034
• Manufacturer Contact: michelle link ; 615 lambert pointe dr.; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 4284228
• MDR Text Key: 5225118
• Report Number: 2916714-2014-00749
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2015
• Device Model Number: C0933210
• Device Catalogue Number: C0933210
• Device Lot Number: 110392V004
• Date Manufacturer Received: 08/28/2014
• 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
• Patient Outcome(s): Other