MalfunctionOGV
TRACHEOSTOMY CLEAN AND CARE TRAY
Received Aug 17, 2012 · Event occurred Aug 9, 2012
Report MW5026585 · MDR key 2711103
Device
Product problems
- Device Contamination with Chemical or Other Material
Patient
50 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
PT BEING CARED FOR AT A HOME. WHEN TRACHEOSTOMY CARE KIT WAS OPENED BY FAMILY MEMBER, BLACK MATTER WAS NOTED ON A GAUZE DRESSING IN THE KIT. THE HOME CARE NURSE SUBSEQUENTLY OPENED ANOTHER KIT FROM THE SAME LOT NUMBER, AND IT ALSO CONTAINED A GAUZE WITH BLACK MATTER ON IT. NEITHER DRESSING WAS USED ON THE PT.