MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS FLO-THRU; CLAMP, VASCULAR

Catalog Number FT12100

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 11/10/2016

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was an ¿adhesive-like object¿ on a flo-thru device.This was observed prior to use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.During a visual and magnification inspection particulate matter was determined to be rtv silicone used when manufacturing the device.The reported condition was verified.The cause of the condition was determined to be due to manufacturing issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: FLO-THRU
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): SYNOVIS SURGICAL INNOVATIONS; saint paul MN
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; saint paul MN 55144
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6284135
• MDR Text Key: 66000981
• Report Number: 1416980-2017-00627
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K981624
• 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,Followup
• Report Date: 03/03/2017

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: Other
• Device Catalogue Number: FT12100
• Device Lot Number: SPH311177487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2017
• Initial Date FDA Received: 01/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2017
• 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: N
• Patient Sequence Number: 1