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	10/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The cap covering the spike of the microtek medical inc.Medi-plast vial decanters comes off in the packaging.Unable to use the vial decanter aseptically because the spike is compromised with the cover off.

• Brand Name: MICROTEK
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): MICROTEK MEDICAL INC.; 602 lehmberg road; columbus MS 39702
• MDR Report Key: 10800444
• Report Number: 10800444
• Device Sequence Number: 16882567
• 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): 10/28/2020
• Report Date (Section F): 10/28/2020

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: 200402
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2020
• 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: 10/28/2020