MAUDE Adverse Event Report: GLOBAL RESOURCES INC. MICROTEK; DECANTER TRANSFER DEVICE

Model Number	2008S
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the decanter transfer device has brown contaminants on the spike, prior to inserting the device in the medication vial.No patient injury, infection, or complications were reported.

• Brand Name: MICROTEK
• Common Device Name: DECANTER TRANSFER DEVICE
• Manufacturer (Section D): GLOBAL RESOURCES INC.; 1805 honggao rd; xiuzhou industry zone; jiaxing, zhejiang 31403 1; CH 314031
• Manufacturer (Section G): GLOBAL RESOURCES INC.; 1805 honggao rd; xiuzhou industry zone; jiaxing, zhejiang 31403 1; CH 314031
• Manufacturer Contact: emily scott ; 1 ecolab pl; st. paul, MN 55102
• MDR Report Key: 14462474
• Report Number: 1043582-2022-00003
• Device Sequence Number: 4637552
• Product Code: KPE
• UDI-Device Identifier: 50748426002530
• UDI-Public: 50748426002530
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K811268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2022

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: Health Professional
• Device Model Number: 2008S
• Device Catalogue Number: N/A
• Device Lot Number: 210923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown