NAMIC 613000165Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10193489074574), received between Nov 17, 2025 and Sep 25, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (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 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionSep 25, 2026Decoupling

  It was reported that "We've had two instances today where the 10 cc syringe on the sub manifold, lawson 488258, p/n 613000165, Lot # 75801, would not stay attached to the manifold."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897833 ↗
• MalfunctionNov 17, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2025 "WHEN ASPIRATING FROM THE PATIENT/CATHETER (BLOOD) OR ANY OTHER PORT THERE WAS NOTED TO BE AIR" IN THE 10ML CONTROL SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23572442 ↗