NAMIC 90701482 (UDI 10193489068337)Recalls & reported problems

Medline Industries, Inc. · PML 48 ADULT FLL-MLL PG · Class 1

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10193489068337), received between Jul 27, 2026 and Sep 28, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break1
Crack1
Fluid/Blood Leak1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 28, 2026Crack; Fluid/Blood Leak
It was reported that "Arterial lines are backing up with blood and when the staff investigate the system, they are finding small cracks in the Pressure Monitoring Tubing causing the tubing to leak and the blood to back up into the line."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915441 ↗
MalfunctionJul 27, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50038275 ↗

Device details

UDI-DI	`10193489068337`
Brand	NAMIC
Model	90701482
Company	Medline Industries, Inc.
Product code	DRI · MONITOR, LINE ISOLATION
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 29, 2023

Device type (GMDN): Invasive blood pressure monitoring tubing set

A collection of devices that includes the necessary tubing and other items, e.g., connectors, stopcock(s), clamps and filters, used as an external connection for invasive blood pressure measurement. This set will interface, either directly or from an intermediate stopcock, between the applied invasive catheter and the measuring transducer. It will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device.

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All MONITOR, LINE ISOLATION devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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