MAUDE Adverse Event Report: MICROTEK MEDICAL LLC MEDLINE-MICROTEK; HUSH-SLUSH¿ 2.0 SLUSH + WARMER DISC-DRAPE

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	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer received a report of microholes/slicing in sterile slushwarmer drapes (sku esd340).Samples and images were provided for evaluation.Visual assessment determined that the reported micro-holes were gel spots, and leak testing showed no water leakage.Gel spots were measured and found to be within the raw material specification acceptance criteria; therefore, the complaint was not confirmed as a product defect.A records-based review of the associated lots identified no related manufacturing nonconformances and the product was manufactured and released per approved procedures.Risk was assessed as low; no field action was required.A quality alert/complaint notification was issued on 19-jan-2026.This is the third reported incident for esd340 within a one-year period; the issue will be tracked and trended.
Event or Problem Description
It was reported that sterile slushwarmer drapes (sku esd340) had "microholes" and slicing during use when water/ice accumulated beneath the drape.Two units from lots 3195la1100 and 5375la0100 were reported.The customer stated only gloved hands were used and no sharps or instruments were involved.

• Brand Name: MEDLINE-MICROTEK
• Common Device Name: HUSH-SLUSH¿ 2.0 SLUSH + WARMER DISC-DRAPE
• 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: 24283571
• Report Number: 3012811961-2026-00003
• Device Sequence Number: 21313976
• Product Code: PUI
• UDI-Device Identifier: 00748426140329
• UDI-Public: 00748426140329
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

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: 3195LA1100 AND 5375LA0100.
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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