inforMED
MalfunctionFOS

UMBILI-CATH

Received Nov 14, 2024 · Event occurred Sep 30, 2024

Report 20682986 · MDR key 20682986

Device

Generic name

Catheter, Umbilical Artery

Catalog number

4285005

Lot number

1212700

Patient

4 DA · Female

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

Narrative

Description of Event or Problem

THE UMBILICAL CATHETER WAS READING OCCLUDED AT [TIME REDACTED]. IT SEEMED TO FLUSH, BUT IT TURNS OUT IT WAS BACK FLUSHING. PRACTITIONER AT BEDSIDE AND LINE WAS REMOVED AFTER TROUBLE SHOOTING IT. LINE APPEARS TO HAVE PRECIPITATE IN IT, ETIOLOGY UNCLEAR. PATIENT DIDN'T GET NUTRITION FOR APPROXIMATELY 2 HOURS. MANUFACTURER RESPONSE FOR CATHETER, UMBILICAL ARTERY, UMBILI-CATH (PER SITE REPORTER). ISSUE WAS REPORTED ON 10/15. THEY RESPONDED ON 10/17 WIT A RETURN LABEL. ON 10/21 REACHED OUT FOR MORE INFO, I INCLUDED THE CLINICAL CAREGIVER TO ANSWER SAID QUESTIONS. NO FURTHER ACTION AS OF 10/23.