MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. OPTILENE 8/0 (0,4) 75CM 2XDR6 CV; CARDIAC SUTURE

Model Number C3090980

Device Problems Device Difficult to Setup or Prepare (1487); Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949)

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

Event Date 07/10/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Complaint states: there are two different problems at this product.One.The withdrawal of the needle is very heavy.You have the feeling that the package is chamber to the back.Due to this you couldn't grab the needle correctly.Two.The withdrawal of the needle is too strong.Due to this, the thread broke very easily during the withdrawal.

Manufacturer Narrative

Us reporting agent notified on: (b)(4) 2014.Manufacturing site evaluation: samples received: 1 unopened racepack.There are no previous complaints of this code batch.There are no units in oem stock.The withdrawal of the needle has been correct and the usual one.After holding the needle, the suture has been pulled out from the pack without difficulty and the usual one.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill oem requirements.Corrective/preventive actions: not applicable.Final conclusion: the complaint is not corresponding (not justified).

• Brand Name: OPTILENE 8/0 (0,4) 75CM 2XDR6 CV
• Type of Device: CARDIAC SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL S.A.; rubi (barcelona) 18034 ; SP 18034
• Manufacturer (Section G): B. BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona ; SP
• Manufacturer Contact: michelle link ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 4047681
• MDR Text Key: 4810810
• Report Number: 2916714-2014-00632
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K061704
• 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: C3090980
• Device Catalogue Number: C3090980
• Device Lot Number: 113381V004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/16/2013
• 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