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

Model Number	ORS-100
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a sterile fluid warmer drape (sku ors-100) was found with a hole, during surgery.One unit from lot 4295la0900 was affected.No images or samples were provided.No patient injuries, infections, or complications were reported.
Additional Manufacturer Narrative
Additional manufacturer narrative (h11): the manufacturer received a report of a hole in a sterile fluid warmer drape (ors-100).No samples, images, or videos were provided or returned; therefore, device evaluation was not performed.A records-based review (including the edhr for lot 4295la0900) and assessment of manufacturing, inspection controls, equipment, and environment identified no related nonconformances.The defect could not be replicated because holes cannot be produced in the manufacturing area; no pinch points were found in the line, and no sharp tools or objects are used in the manufacturing process.The investigation was inconclusive due to lack of returned product or images.Risk was assessed as negligible/low; a quality alert was issued on 19-jan-2026 and the issue will be tracked and trended.This is the third reported incident for ors-100 within a one-year period; trend monitoring is ongoing.

• Brand Name: MEDLINE-MICROTEK
• Common Device Name: WARMER DRAPE, FOR USE WITH ORS-2000 SERIES FLUID WARMING SYSTEM
• 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 ddmingo, santo ddmingo 11606 ; DR 11606
• Manufacturer Contact: yarina montas ; three lakes drive; northfield, IL
• MDR Report Key: 24273564
• Report Number: 3012811961-2026-00002
• Device Sequence Number: 10722761
• Product Code: PUI
• UDI-Device Identifier: 00748426143603
• UDI-Public: 00748426143603
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

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-100
• Device Lot Number: 4295LA0900
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown