MAUDE Adverse Event Report: MICROTEK MEDICAL LLC MEDLINE-MICROTEK; HUSH-SLUSH¿ 2.0 SLUSH + WARMER DISC-DRAPE, FOR USE WITH THE HUSH-SLUSH¿ 2.0

Model Number	ESD340
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer received a report of a slush drape leaking during a surgical procedure.At the end of the case, fluid was observed pooling on the warmer side of the drape.Inspection revealed a section of the drape appeared melted or thinned, which was not noticed during setup.The procedure was completed without delay, and no patient injury occurred.The investigation confirmed the reported condition based on customer information.No sample was returned, and the defect could not be replicated.Device history records were reviewed, and no nonconformances were identified.Manufacturing processes, equipment, materials, and environmental conditions were assessed and found compliant.No changes or issues were identified that could contribute to the reported condition.The root cause could not be determined due to limited information.The event appears isolated, and risk assessment concluded a low risk level.
Event or Problem Description
It was reproted that at the end of the surgical procedure, fluid was observed pooling on the warmer side of the slush drape.Upon inspection, a section of the drape appeared melted or thinned, which was not noticed during setup.The leak allowed saline and surgical contents to collect in the warmer.No patient injuries, infections, or complications were reported.

• Brand Name: MEDLINE-MICROTEK
• Common Device Name: HUSH-SLUSH¿ 2.0 SLUSH + WARMER DISC-DRAPE, FOR USE WITH THE HUSH-SLUSH¿ 2.0
• Manufacturer (Section D): MICROTEK MEDICAL LLC; three lakes drive; northfield 60093
• Manufacturer (Section G): MICROTEK DOMINICANA SAS; las americas free zone park; km 22, autopista las americas; santo ddmingo, santo ddmingo 11606 ; DR 11606
• Manufacturer Contact: yarina montas ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23547827
• Report Number: 3012811961-2025-00013
• Device Sequence Number: 13191489
• Product Code: PUI
• UDI-Device Identifier: 00748426140329
• UDI-Public: 00748426140329
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/13/2025

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
• Device Model Number: ESD340
• 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: 10/15/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2024
• 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