MAUDE Adverse Event Report: SYNERGY HEALTH CARDIAC BASIN/SETUP; BASIN PROCEDURE TRAY, GENERAL SURGERY

Catalog Number 4193C

Device Problems Corroded (1131); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2017

Event Type  malfunction  

Event Description

Staff were opening for a cardiac case.They opened the synergy health cardiac basin/setup.This is a non-disposable stainless steel basin set, contents: carafe, medicine cups x4, and a tray.When the set was opened onto the disposable basin on the sterile field, it was noticed that one of the medicine cups had what resembled gross rust.The "rust" could be easily wiped off.The entire set and the disposable basin it was placed on were removed from the sterile field.No patient contact.

• Brand Name: CARDIAC BASIN/SETUP
• Type of Device: BASIN PROCEDURE TRAY, GENERAL SURGERY
• Manufacturer (Section D): SYNERGY HEALTH; 7086 industrial row rd.; mason OH 45040
• MDR Report Key: 6581333
• MDR Text Key: 75664819
• Report Number: 6581333
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 4193C
• Device Lot Number: 17005
• Other Device ID Number: STERILE W.O. #474434001
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1