MAUDE Adverse Event Report: MICROTEK MEDICAL INC. MICROTEK; CONTAINER, I.V.

Model Number	1
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Microtek vial decanters have a cap on the spike that is inserted into the glass vial.The cap often comes off the spike while in the package therefore compromising the ability to aseptically decant iv fluids from glass vials.

• Brand Name: MICROTEK
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): MICROTEK MEDICAL INC.; 602 lehmberg road; columbus MS 39702
• MDR Report Key: 10592614
• Report Number: 10592614
• Device Sequence Number: 1178238
• Product Code: KPE
• UDI-Device Identifier: 00748426002511
• UDI-Public: (01)00748426002511
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2020
• Report Date (Section F): 09/18/2020

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: 1
• Device Catalogue Number: 2006S
• Device Lot Number: 200318
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/18/2020