inforMED
MalfunctionOXQ

CARDINAL

Received May 11, 2026 · Event occurred Apr 22, 2026

Report 25135103 · MDR key 25135103

Device

Generic name

Dressing Change Tray

Lot number

551397

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

CVL [CENTRAL VENOUS LINE] DRESSING SOILED, WHEN REMOVING DRESSING FOR DRESSING CHANGE CLEAR LAYER SEPARATED FROM WHITE BORDER UNCLEAR IF ALREADY SEPARATED. OF NOTE SIMILAR ISSUE HAS BEEN REPORTED BY 2 OTHER PICU [PEDIATRIC INTENSIVE CARE UNIT] RNS [REGISTERED NURSES] IN THE LAST WEEK AND MULTIPLE OTHER ISSUES REPORTED IN THE PAST. CONCERN THAT THEY MAY BE A MANUFACTURER ISSUE.