MAUDE Adverse Event Report: MICROTEK MEDICAL LLC MEDLINE-MICROTEK; WARMER DRAPE, FOR USE WITH ORS-2000 SERIES FLUID WARMING SYSTEM, 112 CM X 168 CM

Model Number	ORS-300
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During room clean-up, a pool of fluid was identified under a warmer drape.The product involved was ors-300.No patient injury or equipment damage was reported.
Additional Manufacturer Narrative
An investigation was conducted, including review of the 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 nonconformances 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.The findings are consistent with a malfunction observed without conclusive finding, and the cause cannot be established.No immediate corrective or field action is required at this time.The complaint will be documented and monitored as part of routine trending activities.

• Brand Name: MEDLINE-MICROTEK
• Common Device Name: WARMER DRAPE, FOR USE WITH ORS-2000 SERIES FLUID WARMING SYSTEM, 112 CM X 168 CM
• Manufacturer (Section D): MICROTEK MEDICAL LLC; three lakes drive; northfield, il ; DR
• 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: 25538061
• Report Number: 3012811961-2026-00010
• Device Sequence Number: 9617051
• Product Code: PUI
• UDI-Device Identifier: 00748426143627
• UDI-Public: 00748426143627
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/17/2026

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: ORS-300
• Device Lot Number: 2345LA0100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2025
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown