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

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	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/17/2026, (b)(6) hospital reported receiving two (2) sterile ors-300 warmer drapes with holes.No photos, videos, or samples were provided for evaluation.No patient injuries, infections, or complications were reported.
Additional Manufacturer Narrative
The manufacturer received a report that sterile warmer drapes (ors-300), lot 4464la0800 (2 units), arrived with holes.No sample was returned and no photos/videos were provided; the complaint was confirmed based on the customer report.Review of the edhr for lot 4464la0800 ((b)(4) units manufactured from 16-18 nov 2024, 1st and 2nd shift) identified no related nonconformances and the lot was manufactured and released per approved procedures.The condition could not be replicated and the investigation was inconclusive regarding where the nonconformance was generated due to lack of returned sample.Risk was assessed as low (risk level 1); no field action was required.A quality alert/complaint notification was issued on 20-feb-2026 and the issue will be tracked and trended (third similar incident for ors-300 within one year).

• 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 S.A; 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: 24645987
• Report Number: 3012811961-2026-00005
• Device Sequence Number: 10207915
• Product Code: PUI
• UDI-Device Identifier: 00748426143627
• UDI-Public: 00748426143627
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/19/2026

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: 4464LA0800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2024
• 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