inforMED
MalfunctionPEZ

DEROYAL VENOUS PACK

Received Aug 22, 2018 · Event occurred Aug 20, 2018

Report MW5079325 · MDR key 7809274

Device

Generic name

Central Venous Catheter Dressing Change Kit

Manufacturer

Deroyal

Model number

REF # 89-8672.04

Lot number

47260555

Product problems

  • Device Contamination with Chemical or Other Material

Patient

42 YR

  • No Patient Involvement
  • No Patient Involvement

Narrative

Description of Event or Problem

SMALL BLACK SPECK FOUND ON ANGIO TRAY (ON BLUE DRAPE). TRAY NEVER USED, OPENED NEW TRAY.