MAUDE Adverse Event Report: SYNERGY HEALTH NORTH AMERICA; BASIN

Model Number 121716

Device Problems Material Discolored (1170); Contamination /Decontamination Problem (2895)

Patient Problem No Information (3190)

Event Date 11/17/2016

Event Type  malfunction  

Manufacturer Narrative

Even though there were no reported adverse events, the medwatch report is being filed in an abundance of caution.

Event Description

There appeared to be a blue substance and red spots on the stainless basin that is used for solutions in the or.

• Type of Device: BASIN
• Manufacturer (Section D): SYNERGY HEALTH NORTH AMERICA; 7086 industrial row road; mason OH 45040
• Manufacturer (Section G): SYNERGY HEALTH NORTH AMERICA
• Manufacturer Contact: zillery fortner ; 7086 industrial row road; mason, OH 45040
• MDR Report Key: 6182935
• MDR Text Key: 62971705
• Report Number: 0001527607-2016-00001
• Device Sequence Number: 1
• Product Code: FNY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 121716
• Device Catalogue Number: 121716
• Device Lot Number: 538562001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other