inforMED
MalfunctionOFF

MEDLINE INDUSTRIES, INC.

Received Oct 1, 2024 · Event occurred May 27, 2024

Report 20343667 · MDR key 20343667

Device

Generic name

Central Venous Catheter Tray

Model number

DYNDC2002A

Catalog number

DYNDC2002A

Patient

18 YR · Female

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

Narrative

Description of Event or Problem

CAP CHANGE WAS DONE ON [REDACTED DATE] ON THE WHITE LUMEN OF THE CVL. AROUND 0300 THE NEXT DAY ON [REDACTED DATE], MOISTURE WAS NOTED WITHIN THE VALGUARD ON THE LUMEN. UPON FURTHER INSPECTION, IT WAS NOTED THAT THE CAP WAS CRACKED. AT THAT TIME A STERILE CAP CHANGE WAS PERFORMED. THE ORIGINAL CAP CAME FROM A KIT.