Skip to content

Microstream Advance MVABORecalls & reported problems

Oridion Medical 1987 Ltd. · Adult-Intermediate Bite Block CO2 Filter Line with O2 Tubing;Short-term use: Procedural/Emergency · Class 2

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 20884521761732), received between Apr 11, 2022 and May 12, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (2 reports).

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.

Most reported problems

Device problems

  • Device Damaged Prior to Use2

Patient problems

  • Unspecified Tissue Injury2
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionMay 12, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

    ACCORDING TO THE REPORTER, THE BITE BLOCK CAUSED INJURY TO THE GUMS OF THE UPPER JAW OF THE PATIENT DURING THE SEDATION PROCESS. THE CUSTOMER ASKED IF THERE WAS A MATERIAL CHANGE IN MANUFACTURING THIS PRODUCT.

    Patient problems: Unspecified Tissue Injury

    MAUDE report 14377974 ↗
  • MalfunctionApr 11, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

    ACCORDING TO THE REPORTER, THE BITE BLOCK CAUSED INJURY TO THE GUMS OF THE UPPER JAW OF THE PATIENT DURING THE SEDATION PROCESS. THE CUSTOMER ASKED IF THERE WAS A MATERIAL CHANGE IN MANUFACTURING THIS PRODUCT.

    Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

    MAUDE report 14074638 ↗

Other ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE devices

All ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.