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 (ESW

Model Number	ESD340
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer found holes in a sterile drape during use.Two units esd340, were affected.No patient injuries, infections, or complications were reported.
Additional Manufacturer Narrative
The manufacturer received a complaint indicating that holes were observed in a sterile drape (esd340, lot: 4415la0600) during use.No patient injury or equipment damage was reported.An investigation was conducted, including review of device history records, manufacturing processes, and available complaint information.The review confirmed that the lot was manufactured in accordance with established specifications and no related nonconformance's were identified during production or inspection activities.No samples, images, or videos were provided for evaluation, and the reported issue could not be replicated under controlled conditions.As a result, the presence of a device malfunction could not be confirmed through objective evidence.Based on the available information, the investigation did not identify a definitive root cause.

• Brand Name: MEDLINE-MICROTEK
• Common Device Name: HUSH-SLUSH¿ 2.0 SLUSH + WARMER DISC-DRAPE, FOR USE WITH THE HUSH-SLUSH¿ 2.0 (ESW
• Manufacturer (Section D): MICROTEK MEDICAL LLC; three lakes drive; northfield IL
• Manufacturer (Section G): MICROTEK DOMINICANA SAS; las americas free zone park; km 22, autopista las americas; santo domingo, santo domingo 11606 ; DR 11606
• Manufacturer Contact: yarina montas ; three lakes drive; northfield, IL
• MDR Report Key: 25555051
• Report Number: 3012811961-2026-00011
• Device Sequence Number: 21103039
• Product Code: PUI
• UDI-Device Identifier: 00748426140329
• UDI-Public: 00748426140329
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

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: 4415LA0600
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown