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	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a hole was suspected in a fluid warmer drape (ors-300) during use in a surgical procedure.One unit was affected.The lot number was not provided.No patient injuries or complications were reported.
Additional Manufacturer Narrative
It was reported that fluid was observed beneath a fluid warmer drape (ors-300) following a surgical procedure.One unit was affected.No lot number was provided and no injury or complication was reported.No samples or photographs were received; the nonconforming condition was confirmed based on the customer's description.Because no lot number was provided, the device history record could not be reviewed.Evaluation of the applicable 6m variables identified no manufacturing-origin cause, and a review of historical data for ors-300 did not identify an adverse trend.The root cause is undetermined and the investigation is inconclusive.

• 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
• Manufacturer (Section G): MICROTEK DOMINICANA SAS; zona franca no. 2; la romana, la romana 22000 ; DR 22000
• Manufacturer Contact: yarina montas ; three lakes drive; northfield, IL
• MDR Report Key: 50899761
• Report Number: 8043817-2026-00005
• Device Sequence Number: 6001693
• Product Code: PUI
• UDI-Device Identifier: 00748426143627
• UDI-Public: 00748426143627
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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