NAMIC 60141021Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10193489048162), received between Jul 3, 2025 and Jul 3, 2025 — classified as 1 malfunction.

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

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 27, 2026Open, Classified

   Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

   Z-1718-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionJul 3, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE ROTATING ADAPTER IS VERY TIGHT, AND THE CUSTOMER HAS TO TURN IT MULTIPLE TIMES TO EASE THE STIFFNESS PRIOR TO ATTACHING IT TO THE MANIFOLD. THE CUSTOMER STATED THAT OTHERWISE, THE SYRINGE STARTS TO LOOSEN FROM THE MANIFOLD AND THAT SOMETIMES THE TORQUE FROM THE SYRINGE ATTACHED TO THE MANIFOLD STARTS TO LOOSEN AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394975 ↗