MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. DAFILON BLUE 4/0 (1.5) 45CM DS19; NYLON SUTURE

Model Number C0932205

Device Problems Break (1069); Device Damaged Prior to Use (2284)

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).Sutures keep on breaking in use.

Manufacturer Narrative

Us reporting agent notified on: (b)(4) 2014.Manufacturing site evaluation: samples received: 22 unopened pouches.There are no previous complaints of this code/batch.There are no units in oem stock.Tested the knot pull tensile strength of the closed sample 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 fulfill oem requirements.Final conclusion: the complaint is not corresponding (not justified).Corrective/preventive actions: not applicable.

• Brand Name: DAFILON BLUE 4/0 (1.5) 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; rubi (barcelona) 0819 1; SP 08191
• Manufacturer Contact: michelle link ; 615 lambert pointe dr.; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 4040641
• MDR Text Key: 4903192
• Report Number: 2916714-2014-00602
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• 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: 08/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2018
• Device Model Number: C0932205
• Device Catalogue Number: C0932205
• Device Lot Number: 613332
• 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