MAUDE Adverse Event Report: MICROTEK MEDICAL LLC MEDLINE-MICROTEK; SLUSH + WARMER PLATE-DRAPE¿, FOR USE WITH ORS-1058 HUSH-SLUSH¿

Model Number	ORS-330N
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The facility reported that a slush drape from a valve pack leaked during a surgical procedure.A hole was discovered at the end of the case when the drape was removed from the warmer, revealing saline and surgical contents pooled at the bottom of the machine.The procedure was completed without delay.No injury or medical intervention was required; however, additional antibiotics were administered as a precaution per the surgeon and anesthesia team's recommendation.No patient injuries, infections, or complications were reported.
Additional Manufacturer Narrative
Medline received a complaint from (b)(6) hospital on (b)(6) 2025, regarding two non-sterile slush warmer plate drapes (part number: ors-330n) that leaked during use due to holes in the material.The defect was confirmed based on customer-provided images; however, no physical samples were returned.A thorough investigation was conducted, including evaluation of manufacturing processes, equipment, materials, personnel, and environmental conditions.No issues or changes were identified that could contribute to the reported defect.All relevant procedures and quality controls were found to be properly implemented and effective, including visual inspections and first article evaluations.No similar complaints were reported for this product in the past year.The defect could not be replicated, and the root cause remains undetermined.The risk assessment concluded a low risk level, and no corrective or field actions were deemed necessary.A quality alert was issued, and ongoing monitoring of complaint trends will continue.

• Brand Name: MEDLINE-MICROTEK
• Common Device Name: SLUSH + WARMER PLATE-DRAPE¿, FOR USE WITH ORS-1058 HUSH-SLUSH¿
• Manufacturer (Section D): MICROTEK MEDICAL LLC; three lakes drive; northfield 60093
• 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 60093
• MDR Report Key: 23538724
• Report Number: 3012811961-2025-00012
• Device Sequence Number: 21275949
• Product Code: PUI
• UDI-Device Identifier: 00748426140466
• UDI-Public: 00748426140466
• Combination Product (Y/N): N
• 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): 11/12/2025

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-330N
• Device Lot Number: 254LA1200, 314LA0400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 11/12/2025
• 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: Male