MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 4/0 (1,5) 90CM 2XHR22F CV RCP; CARDIAC SUTURE

Model Number C3096010

Device Problems Dull, Blunt (2407); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: analysis and results.No samples or batch number is available.As no batch number is available, the batch manufacturing record cannot be reviewed.We have not received any sample for analysis.Final conclusion: without sample or involved batch number, we are not able to study if the affected product fulfills the specifications.In consequence, a proper analysis cannot be done.Nevertheless, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyze it.

Event Description

It was reported that there was an issue with an optilene suture.During an unspecified procedure, the needle became blunt after a few stitches; and it was also noted that the suture was not "smooth" enough.There was no surgical delay due and the patient outcome was "good".Additional information is not available.

• Brand Name: OPTILENE 4/0 (1,5) 90CM 2XHR22F CV RCP
• Type of Device: CARDIAC SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 8500796
• MDR Text Key: 141760918
• Report Number: 3003639970-2019-00326
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K180321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/10/2019

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: C3096010
• Device Catalogue Number: C3096010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/25/2019
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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