inforMED
MalfunctionPEZ

DEROYAL VENOUS PACK BOWL

Received Jan 9, 2017 · Event occurred Dec 21, 2016

Report MW5067149 · MDR key 6237721

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

22 YR

  • No Patient Involvement
  • No Patient Involvement

Narrative

Description of Event or Problem

OPENED A STERILE VENOUS PACK FOR A PROCEDURE AND NOTED A COUPLE OF BLACK SPECKS IN THE STERILE BOWL. WHEN ADDING SALINE TO BOWL, THE BLACK SPECKS FLOATED. DISCARDED TRAY AND RETRIEVED NEW ONE FOR PROCEDURE.