MalfunctionFOS

3.5 FRENCH SINGLE LUMEN SILICONE UMBILICAL CATHETER

Received Jun 7, 2024 · Event occurred Jan 5, 2024

Report 19483216 · MDR key 19483216

Device

Generic name

Catheter, Umbilical Artery

Manufacturer

Footprint Medical, Inc.

Model number

S1UVC-3540

Lot number

220096

Patient

3 DA · Male

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

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.