Jelco 4141Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10351688028969), received between Oct 8, 2024 and Oct 8, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Disconnection” (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. 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.

• MalfunctionOct 8, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE NEEDLES COME OUT OF THE NEEDLE HOLDERS MID-DRAW, WHICH IS CONSIDERED A SAFETY HAZARD. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20402512 ↗
• MalfunctionOct 8, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT A HALF DOZEN NEEDLES OF DIFFERENT VARIETIES HAVE FALLEN FROM NEEDLE HOLDERS WHILE CHANGING TUBES DURING PATIENT DRAWS. SOME PATIENTS HAVE HAD TO BE REDRAWN. THERE WAS A PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20399040 ↗