MAUDE Adverse Event Report: MICROTEK MEDICAL INC. MICROTEK MEDICAL INC.; VIAL DECANTER

Model Number	2006S
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the vial decanter spike cap came off in the packaging which compromised the users' ability to aseptically decant iv fluids.No patient injury was reported.

• Brand Name: MICROTEK MEDICAL INC.
• Common Device Name: VIAL DECANTER
• Manufacturer (Section D): MICROTEK MEDICAL INC.; 602 lehmberg road; columbus MS 39702
• MDR Report Key: 10983446
• Report Number: 1043582-2020-00009
• Device Sequence Number: 4396535
• Product Code: KPE
• UDI-Device Identifier: 50748426002516
• UDI-Public: 50748426002516
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K811269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 12/10/2020

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: No Information
• Device Model Number: 2006S
• Device Catalogue Number: NOT REPORTED BY USER
• Device Lot Number: NOT REPORTED BY USER
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1