MalfunctionPEZ

DEROYAL VENOUS PACK BOWL

Received Jan 9, 2017 · Event occurred Jan 6, 2017

Report MW5067148 · MDR key 6237712

Device

Generic name

Venous Pack Bowl 16 Oz

Manufacturer

Deroyal

Model number

89-8672.02

Lot number

43483479

Product problems

Device Contamination with Chemical or Other Material

Patient

63 YR

No Patient Involvement
No Patient Involvement

Narrative

Description of Event or Problem

STERILE TRAY OPENED FOR PROCEDURE NOTED BLACK SPECK IN STERILE BOWL. NO SALINE OR OTHER PRODUCTS ADDED TO BOWL. BLACK SPECK IS LOOSE AND MOVES. NO PARTS OF THIS TRAY CAME IN CONTACT WITH PT.