NA S1UVC-3540Recalls & reported problems
Footprint Medical, Inc. · 3.5Fr Single Lumen Silicone Umbilical Catheter · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00858778006324), received between Jun 7, 2024 and Jun 7, 2024 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 7, 2024
NEWBORN PATIENT IN NEONATE INTENSIVE CARE UNIT (NICU) ISOLETTE MOVING ABOUT VIGOROUSLY. WHEN REGISTERED NURSE (RN) SETTLED BABY AND CHANGED HIS DIAPER, HIS 3.5 UMBILICAL CATHETER BROKE ABOUT 1.5 TO 2 INCHES AFTER THE TOTAL PARENTERAL NUTRITION (TPN) FILTER OR ABOUT 2-3 INCHES FROM THE INSERTION SITE. NO HARM TO PATIENT NOTED. ALL CATHETERS WITH SAME LOT NUMBER WERE TESTED AND BROKE VERY EASILY. REMOVED BY SUPPLY CHAIN. MANUFACTURER RESPONSE FOR CATHETER, UMBILICAL ARTERY, NA (PER SITE REPORTER): UNKNOWN AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19483216 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.