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SAFEDRAW(TM) DT-4812SDT 682142Recalls & reported problems

Argon Critical Care Systems Singapore Pte. Ltd. · A 1-way 60 drops with 60" tube Adset connected to a 3cc transducer. The Safedraw is assembled with a 5cc restricted syringe stops at 2cc, with a 12" Pressure Tubing from the patient and a 48" Pressure tubing to the syringe. It also includes a separately packed 2x male protective caps and a Label Set. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886333621422), received between Sep 16, 2020 and Sep 16, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Fluid/Blood Leak1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

    THE ACCOUNT ALLEGES THAT THE THERE IS A LEAK BETWEEN THE TUBING AND THE SAFEDRAW P SEPTUM. NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10543404 ↗

Other System, Measurement, Blood-Pressure, Non-Invasive devices

All System, Measurement, Blood-Pressure, Non-Invasive devices →

Sources and updates

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