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

Model Number	ORS-100
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer received a complaint indicating that a sterile warming drape (ors-100) exhibited tiny pin-size holes during use.One unit was affected; however, the lot number could not be confirmed.No physical sample was returned for evaluation; therefore, the investigation was based on an image provided by the customer.The reported defect was confirmed based on the available evidence, but the condition could not be replicated.A review of manufacturing, material, process, equipment, environmental, and personnel factors did not identify any contributing cause.Device traceability could not be established due to the absence of a valid lot number.Based on the available information, the investigation was determined to be inconclusive.The complaint will continue to be monitored for potential trend.
Event or Problem Description
It was reported that the customer observed tiny pin-size holes in a sterile warming drape (ors-100) during use.One unit was affected.The lot number could not be confirmed.No patient injuries, infections, or complications were reported.

• Brand Name: MEDLINE-MICROTEK
• Common Device Name: WARMER DRAPE, FOR USE WITH ORS-2000 SERIES FLUID WARMING SYSTEM, 112 CM X 112 CM
• 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: 25602397
• Report Number: 3012811961-2026-00012
• Device Sequence Number: 21310964
• Product Code: PUI
• UDI-Device Identifier: 00748426143603
• UDI-Public: 00748426143603
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/23/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2026
• 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