WARMER DRAPE
Received Dec 8, 2016
Report 8043817-2016-00052 · MDR key 6156081
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-400Lot number
D161621
Product problems
- Hole In Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DRAPE THAT WAS REPORTED TO HAVE THE NONCONFORMITY WAS RECEIVED FOR EVALUATION. THE ONLY "HOLES" IN THE DRAPE ARE THE SLITS THAT ALLOW AIR TO ESCAPE FROM THE POCKET THAT CONTAINS THE FOAM PILLOW. THE SLITS ARE ON THE UNDERSIDE (NONSTERILE) SIDE OF THE DRAPE AND ARE THERE BY DESIGN TO ALLOW AIR TO ESCAPE. THERE ARE TWO SMALL SPOTS AROUND THE SEALED AREA THAT CONTAINS THE FOAM PILLOW. THESE COULD BE MISTAKEN AS SMALL HOLES IN APPEARANCE, BUT THESE WERE TESTED BY POURING WATER OVER THEM. NO LEAKS WERE OBSERVED. NO OTHER HOLES OR TEARS WERE NOTED IN THE SAMPLE RETURNED. THE DHR WAS REVIEWED FOR LOT D161621- THIS LOT HAD (B)(4) PIECES AND IT WAS MANUFACTURED ON 06/10/16. NO DEFECTS RELATED TO THE NON CONFORMANCE WERE REPORTED DURING THE PROCESS, PACKAGING OR FINAL INSPECTION. THIS LOT WAS MANUFACTURED IN COMBINED SHIFT. BASED ON THE SAMPLE AND DHR REVIEW, THE ISSUE APPEARS TO BE THE RESULT OF USER PERCEPTION.
Description of Event or Problem
A HOLE WAS DISCOVERED IN THE DRAPE AS THE CASE WAS BEING SET UP AND THE WARMER MACHINE WAS BEING DRAPED.