MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. OPTILENE 4/0 (1,5) 90CM 2XHR26F CV RCP; SUTURE

Model Number C3095611

Device Problems Material Separation (1562); Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: date of event: (b)(6) 2018.Patient information: not available.Samples received: 1 open and used unit.Analysis and results: there are no previous complaints of this code-batch.Manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in stock.Received one open and used sample with the thread broken and shows splitting.However, without any closed sample an analysis can not be carried out in order to make a decision.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill the oem requirements.Final conclusion: in spite of receiving a defective sample, without closed samples a suitable analysis cannot be performed.Nevertheless, note of this incident is taken and if any closed sample is received in the future, the case will be re-opened and analyzed.

Event Description

It was reported that during a cardio surgery,"the thread rifted up (blossomed up).".

• Brand Name: OPTILENE 4/0 (1,5) 90CM 2XHR26F CV RCP
• Type of Device: SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL S.A.; 121 carretera de terrassa; rubi (barcelona), 08191 ; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL S.A.; 121 carretera de terrassa; rubi (barcelona), 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 7971763
• MDR Text Key: 123962013
• Report Number: 3003639970-2018-00653
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: K133890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C3095611
• Device Catalogue Number: C3095611
• Device Lot Number: 118161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Distributor Facility Aware Date: 09/28/2018
• Initial Date Manufacturer Received: 09/19/2018
• Initial Date FDA Received: 10/16/2018
• 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