MAUDE Adverse Event Report: MICROTEK MEDICAL LLC MEDLINE-MICROTEK; PATIENT DRAPE, LINGEMAN CYSTO / URO DRAIN BAG - SKYTON / STERIS / PICKER TABLES

Model Number	LG3000-A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A drainage bag leaked during intraoperative use, causing fluid exposure to staff and spillage that impeded fluid tracking.Staff reported difficulty positioning the bag, sometimes requiring patient lifting, creating ergonomic risk.No patient injury reported.Lot 2105lr4300 (lg3000-a) was manufactured 15-17 mar 2025 at la romana facility, plant 1.Device not returned; evaluation included complaint review and edhr check no nonconformances found.Investigation suggests a manufacturing deficiency, but root cause could not be confirmed without the sample.Risk assessed as low; corrective actions included quality alert and retraining.
Event or Problem Description
It was reported that during intraoperative use of the drainage bag, fluid leaked onto clinical staff, resulting in direct exposure to blood and spillage onto the floor.The spillage impeded accurate tracking of hysteroscopic fluid usage.Staff reported the bag is challenging to position/operate intraoperatively.In some cases, nurses/techs needed to physically lift patients to place the bag under the buttocks, creating potential ergonomic injury risk.No patient injuries, infections, or complications were reported.

• Brand Name: MEDLINE-MICROTEK
• Common Device Name: PATIENT DRAPE, LINGEMAN CYSTO / URO DRAIN BAG - SKYTON / STERIS / PICKER TABLES
• Manufacturer (Section D): MICROTEK MEDICAL LLC; three lakes drive; northfield 60093
• 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 60093
• MDR Report Key: 23330532
• Report Number: 8043817-2025-00009
• Device Sequence Number: 15939865
• Product Code: FNP
• UDI-Device Identifier: 00748426144266
• UDI-Public: 00748426144266
• Combination Product (Y/N): N
• 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): 10/17/2025

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: LG3000-A
• Device Lot Number: 2105LR4300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown