MEDLINE DYNDA2665Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10193489191899), received between Jul 20, 2022 and Jul 20, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

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

• MalfunctionJul 20, 2022Break; Retraction Problem

  WHILE PLACING UMBILICAL LINES ON A PREMATURE INFANT WITH THE STANDARD UMBILICAL LINE KIT KEPT IN THE NICU. MD CUT THE CORD DOWN WITH THE LIGHT BLU SCALPEL AND WHEN MD PRESSED THE BUTTON TO RETRACT THE NEEDLE BACK INTO THE DEVICE, THE SCAPEL SHOT BACK AT MD (NOT THE SHARP PART) AND FELL TO THE GROUND. MD WAS NOT STRUCK BY THE SCAPEL AND NO ONE WAS HARMED, BUT THE SCAPEL CERTAINLY SEEMS LIKE IT WAS BROKEN IN SOME WAY. SCALPEL WAS DISPOSED. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THERE WAS NO HARM TO PROVIDER OR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064635 ↗