MAUDE Adverse Event Report: MICROTEK MEDICAL LLC MEDLINE-MICROTEK; ROLLED PROBE COVER, 3.5 CM X 20 CM (1.4 IN X 8 IN)

Model Number	PC0907NS
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product is supplied by medline/microtek as non-sterile for inclusion in procedure kits.Sterilization and final kit assembly are performed by the kit packers.Since downstream sterilization and kit assembly is outside the manufacturing site scope for this complaint, the investigation focuses on the reported material integrity issue for the product as supplied and the available production and quality records reviewed.Additional reported lot numbers associated with this complaint: d212351; 4073lro000; 5084lrj700.
Event or Problem Description
It was reported that all (16) probe covers were compromised inside the packaging, with material appearing damaged and adhered to the pouch.No patient injuries, infections, or complications were reported.

• Brand Name: MEDLINE-MICROTEK
• Common Device Name: ROLLED PROBE COVER, 3.5 CM X 20 CM (1.4 IN X 8 IN)
• 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: 24404627
• Report Number: 8043817-2026-00001
• Device Sequence Number: 15885486
• Product Code: PUI
• UDI-Device Identifier: 00748426261611
• UDI-Public: 00748426261611
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/20/2026

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: PC0907NS
• Device Lot Number: 4084LR1M00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 02/20/2026
• 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