MalfunctionFNY
CARDINAL PRESOURCE
Received Jun 19, 2017 · Event occurred Jun 6, 2017
Report 6650448 · MDR key 6650448
Device
Generic name
Sterile Major Basin Pack
Manufacturer
Cardinal HealthModel number
SUT21MBARDCatalog number
SUT21MBARD
Lot number
691768
Product problems
- Hole In Material
- Sticking
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DURING SETUP OF AN OPERATING ROOM (OR) PROCEDURE, THE NURSE/SCRUB TECH OPENED A MAJOR BASIN SET-UP PACK. THE BACK TABLE COVER WAS REMOVED TO DRAPE ON THE TABLE. THE DRAPE WAS STUCK TO ITSELF AND WOULD NOT UNFOLD PROPERLY. ADDITIONALLY THERE WAS A HOLE IN THE DRAPE, POSSIBLY FROM TRYING TO OPEN THE DRAPE. ANOTHER PACK WAS USED WITHOUT INCIDENT. NO PATIENT INJURY.