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

Model Number 1

Device Problem Material Separation (1562)

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

Event Date 09/16/2020

Event Type  malfunction  

Event 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
• Type of Device: CONTAINER, I.V.
• Manufacturer (Section D): MICROTEK MEDICAL INC.; 602 lehmberg road; columbus MS 39702
• MDR Report Key: 10592614
• MDR Text Key: 208747318
• Report Number: 10592614
• Device Sequence Number: 1
• Product Code: KPE
• UDI-Device Identifier: 00748426002511
• UDI-Public: (01)00748426002511
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1
• Device Catalogue Number: 2006S
• Device Lot Number: 200318
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/18/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1