inforMED
MalfunctionFOS

ARGYLE

Received Aug 28, 2024 · Event occurred Jul 1, 2024

Report 20084785 · MDR key 20084785

Device

Generic name

Catheter, Umbilical Artery

Model number

8888160333

Catalog number

8888160333

Lot number

2405900108

Patient

NA · Prefer Not To Disclose

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

Narrative

Description of Event or Problem

"SITUATION: FAULTY SINGLE LUMEN UAV CATHETER. BACKGROUND: TERM INFANT WITH SEVERE PPHN (PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN) REQUIRING UAC AFTER ADMISSION. ASSESSMENT: APP'S ATTEMPTING TO PLACE 3.5FR UAC. CATHETER WAS FLUSHED WITH HEPARINIZED NORMAL SALINE PRIOR TO INSERTION PER POLICY. CATHETER WAS THEN INSERTED WITH POSITIVE BLOOD RETURN. WHEN ATTEMPTING TO DRAW BLOOD SAMPLES FROM THE LINE, BLOOD WAS ABLE TO BE DRAWN BACK TO THE FUSE AND THEN STOPPED. APP'S WERE UNABLE TO DRAW ANY ADDITIONAL BLOOD BACK OR FLUSH ANY HEP. SALINE FORWARD. RECOMMENDATION: LINE WAS WITHDRAWN AND NEW LINE PLACED. FAULTY CATHETER LEFT IN CARE OF APSM." MANUFACTURER RESPONSE FOR SINGLE LUMEN UAV CATHETER, SINGLE LUMEN UAV CATHETER (PER SITE REPORTER). SAMPLE COLLECTED AND MEDLINE EMAILED.