inforMED
MalfunctionPEZ

DEROYAL VENOUS PACK SET UP COVER

Received Jul 17, 2018 · Event occurred Jul 12, 2018

Report MW5078437 · MDR key 7697652

Device

Generic name

Central Venous Catheter Pressing Change Kit

Catalog number

89-8672.04

Lot number

47260555

Product problems

  • Device Contamination with Chemical or Other Material

Patient

30 YR

  • No Patient Involvement
  • No Patient Involvement

Narrative

Description of Event or Problem

VENOUS PACK LOT # 47260555 WAS OPENED FOR A PT PROCEDURE. A BLACK FOREIGN BODY WAS NOTED ON THE DRAPE WHEN PREPARING THE TRAY. NO PART OF THE TRAY CAME INTO CONTACT WITH PT. THE TRAY WAS REMOVED AND ANOTHER TRAY OPENED.