MalfunctionPEZ

DEROYAL VENOUS PACK BOWL

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

Report MW5067147 · MDR key 6237708

Device

Generic name

Venous Pack Bowl

Manufacturer

Deroyal

Model number

89-8672.02

Lot number

41798522

Product problems

Device Contamination with Chemical or Other Material

Patient

58 YR

No Known Impact Or Consequence To Patient
No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

OPENED STERILE VENOUS PACK LOT #41798522 FOR PT'S PROCEDURE, LOOSE BLACK SPECK NOTED IN STERILE BOWL. NO SALINE OR OTHER PRODUCTS ADDED TO STERILE BOWL. ENTIRE STERILE TRAY DRAPE FOLDED OVER AND CLOSED IMMEDIATELY AND REMOVED.