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	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer investigated a reported defect involving holes in the product.Device history records for the affected lot were reviewed, and no nonconformance was identified during manufacturing.All established procedures and quality controls were confirmed as adequate, and the defect could not be replicated under controlled conditions.Due to the absence of samples or supporting evidence, the root cause could not be conclusively determined.Risk assessment classified the issue as low.Immediate actions included issuing a quality alert and initiating trend monitoring for similar complaints.
Event or Problem Description
It was reported that the or staff noticed the slush drape esd340 had a hole.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: 23680721
• Report Number: 3012811961-2025-00014
• Device Sequence Number: 9846903
• Product Code: PUI
• UDI-Device Identifier: 00748426140329
• UDI-Public: 00748426140329
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/01/2025

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
• Device Lot Number: 5374LA1600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown