MAUDE Adverse Event Report: B. BRAUN SURGICAL OPTILENE 4/0 (1, 5) 90CM 2XHR26 CV RCP; CARDIAC SUTURE

Model Number C3090907

Device Problems Crack (1135); Material Integrity Problem (2978)

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

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Thread (suture) splitting.

Manufacturer Narrative

Us reporting agent notification received: (b)(6)2014.Complaint description: thread (suture) splitting.Samples received: 1 open race pack.Analysis and results: there are no previous complaints of this code batch.There are no units in oem stock.Oem received one open and used sample with splitting thread.Without any closed sample we cannot carry out an analysis in order to make an informed decision.Reviewed the batch mfg record, this product had a normal process and the results during the process conform to requirements.Final conclusion: the complaint is not corresponding (not justified).Actions on product: na.Corrective/preventive actions: na.

• Brand Name: OPTILENE 4/0 (1, 5) 90CM 2XHR26 CV RCP
• Type of Device: CARDIAC SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL; carretera de terrassa SA 1 21
• Manufacturer (Section G): B. BRAUN SURGICAL SA; 121 carretera de terrassa; rubi (barcelona) ES 0 8191; SP ES 08191
• Manufacturer Contact: michelle link ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 4368143
• MDR Text Key: 20018422
• Report Number: 2916714-2014-01020
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K061704
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/01/2008
• Device Model Number: C3090907
• Device Catalogue Number: C3090907
• Device Lot Number: 113405
• Date Manufacturer Received: 10/27/2014
• 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