FDA Adverse Event Malfunction Summary report: N

MEDLINE-MICROTEK

MDR report key: 23330532 · Received October 17, 2025

Report

Report Number: 8043817-2025-00009
Event Type: Malfunction
Date Received: October 17, 2025
Date of Event: September 18, 2025
Report Date: October 17, 2025
Manufacturer: MICROTEK MEDICAL LLC
Product Code: FNP
UDI-DI: 00748426144266
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

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.

Description of Event or Problem · 0

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
299935	MEDLINE-MICROTEK	PATIENT DRAPE, LINGEMAN CYSTO / URO DRAIN BAG - SKYTON / STERIS / PICKER TABLES	FNP	MICROTEK MEDICAL LLC	LG3000-A	2105LR4300	00748426144266

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown