MalfunctionOFF
MEDLINE
Received Nov 2, 2021 · Event occurred Oct 26, 2021
Report 12739769 · MDR key 12739769
Device
Generic name
Central Venous Catheter Tray
Model number
DYNDC1987ACatalog number
DYNDC1987A
Lot number
(10) 21FBL800
Product problems
- Component Missing
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
WHEN OPENING CUSTOM DRESSING CHANGE KIT, KIT STATES THAT A BIOPATCH IS INCLUDED. THE BIOPATCH IS MISSING. IN THE KIT IS A DEROYAL ALGIDEX AG IV PATCH SILVER ALGINATE. THIS PRODUCT HAS NOT BEEN APPROVED BY OUR INFECTION PREVENTION PROGRAM AND STAFF ARE NOT TRAINED ON THE USE OF IT.