NA P2UVC3.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00858778006539), received between Jun 2, 2022 and Sep 15, 2026 — classified as 1 injury, 2 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776467 ↗
• MalfunctionSep 15, 2025Crack; No Flow

  THIS NURSE WENT TO TAPED UVC [UMBILICAL VENOUS CATHETER] TO INFANT'S ABDOMEN AND NOTICED THE UVC WAS NOT INTACT/APPEARS CRACKED. FLUIDS WERE NOT INFUSING YET, NO BLOOD/FLUID WAS COMING OUT OF CRACK.

  Patient problems: Insufficient Information

  MAUDE report 23050430 ↗
• InjuryJun 2, 2022Break; Stretched; Break; Stretched

  THE UMBILICAL CATHETER WAS REPORTED TO HAVE BEEN PLACED IN THE UMBILICAL VEIN OF A NEWBORN BABY. AFTER SUCCESSFULLY COMPLETING THE COURSE OF THERAPY, THE CATHETER WAS REMOVED. UPON EXTRACTION, THE NNP NOTICED THAT THE TIP APPEARED JAGGED AND STRETCHED. CONCERNED THAT THE TIP MAY HAVE BROKEN OFF IN THE PATIENT, AN X-RAY WAS PERFORMED WHICH REVEALED NO INDICATION OF A PIECE OF THE CATHETER BEING LEFT INSIDE THE PATIENT. PER THE HOSPITAL, NO PATIENT HARM WAS FOUND AND NO FURTHER ACTIONS WERE TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14576388 ↗