MAUDE Adverse Event Report: ECOLAB VIAL DECANTER; IV CONTAINER

Model Number	2006S
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shavings were observed underneath the cap on the pointed end of the decanter.It was noted that three decanters had this issue.No patient complications have been reported as a result of this event.

• Brand Name: VIAL DECANTER
• Common Device Name: IV CONTAINER
• Manufacturer (Section D): ECOLAB; 1 ecolab place; st paul MN 55102
• MDR Report Key: 8680297
• Report Number: 8043817-2019-00023
• Device Sequence Number: 14210676
• Product Code: KPE
• UDI-Device Identifier: 50748426002516
• UDI-Public: 50748426002516
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K811269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/21/2024
• Device Model Number: 2006S
• Device Lot Number: 181112
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2019
• Patient Sequence Number: 1