NAMIC 90701122Recalls & reported problems

Medline Industries, Inc. · PML 12 ADULT FLL-MLL PG · Class 1

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 10193489068306), received between Sep 22, 2026 and Sep 25, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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

Appropriate Device Problem Term/Code Not Available1
Gas/Air 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 25, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905113 ↗
MalfunctionSep 22, 2026Gas/Air Leak
It was reported that "During PCI, PML was used as connected to OKAY Y-adapter (goodman), however air was withdrawn."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852837 ↗

Device details

UDI-DI	`10193489068306`
Brand	NAMIC
Model	90701122
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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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.