inforMED
MalfunctionFOS

ARGYLE

Received Aug 22, 2024 · Event occurred Jun 23, 2024

Report 20031585 · MDR key 20031585

Device

Generic name

Catheter, Umbilical Artery

Model number

8888160556

Catalog number

8888160556

Lot number

2305800141

Patient

NA · Prefer Not To Disclose

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

Narrative

Description of Event or Problem

"FAULTY DUAL LUMEN UVC FOUND DURING LINE PLACEMENT. INFANT TO RECEIVE A DUAL LUMEN UVC, APP WAS UNABLE TO FLUSH HEPARINIZED SALINE THROUGH BLUE (SECONDARY) LUMEN. NEW CATHETER UTILIZED SUCCESSFULLY. FAULTY CATHETER LEFT IN CUSTODY OF APSM. AVAILABLE INFORMATION: MFG: COVIDIEN. PRODUCT: ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER. DUAL LUMEN, 5FR X 9-8/10" (25CM), REFERENCE#: 8888160556, LOT#: 2305800141." MANUFACTURER RESPONSE FOR DUAL LUMEN UVC , ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER, DUAL LUMEN UVC , ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER (PER SITE REPORTER), NOTIFIED MEDLINE [REDACTED DATE].