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

Catalog Number 2008S

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2022

Event Type  malfunction  

Event Description

The nurse opened the decanter transfer device and noticed brown contaminants on the spike prior to inserting the device in the medication vial.The nurse obtained a new device and did not use the contaminated device.The nurse saved the device to give to materials management.

• Brand Name: MICROTEK
• Type of Device: CONTAINER, I.V.
• Manufacturer (Section D): MICROTEK MEDICAL INC.; 1 ecolab place; saint paul MN 55102
• MDR Report Key: 14353450
• MDR Text Key: 294396914
• Report Number: 14353450
• Device Sequence Number: 1
• Product Code: KPE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2008S
• Device Lot Number: 210923
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1