MalfunctionPEZ
DEROYAL VENOUS PACK BOWL
Received Jan 9, 2017 · Event occurred Jan 6, 2017
Report MW5067146 · MDR key 6237685
Device
Product problems
- Device Contamination with Chemical or Other Material
Patient
66 YR
- No Patient Involvement
- No Patient Involvement
Narrative
Description of Event or Problem
OPENED STERILE VENOUS PACK LOT #43483479 TO PREP FOR PT PROCEDURE. NOTED A SMALL BACK SPECK IN STERILE BOWL. NO SALINE OR OTHER PRODUCTS WERE ADDED TO THE BOWL. BLACK SPECK IS LOOSE AND MOVES IN BOWL. THE ENTIRE DRAPE WAS FOLDED, AND CLOSED AND ENTIRE TRAY NOT USED. THIS WAS NOTED BEFORE ANY PROCEDURE AND NO PRODUCTS FROM THIS TRAY CAME IN CONTACT WITH THE PT.