WARMER DRAPE
Received Jan 3, 2017
Report 8043817-2017-00001 · MDR key 6219443
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-300NLot number
D153281A
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. DURING INITIAL REVIEW OF THE DRAPE, A HOLE COULD NOT BE LOCATED. THE DRAPE WAS THEN PUT ON A WARMER AND WATER WAS ADDED. A SLIT WAS THEN LOCATED. THE SLIT LOOKED TO BE MADE BY A SHARP OF SOME KIND THAT WAS PLACED IN THE BASIN. THE DHR WAS REVIEWED FOR LOT D153281A. THIS LOT HAD (B)(4) PIECES AND IT WAS MANUFACTURED ON 11/24/16. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. BASED ON THE REVIEW OF THE SAMPLE AND THE DEVICE HISTORY RECORD, THE NON CONFORMANCE DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS, OR MATERIAL ISSUE. IT APPEARS THAT THE "HOLE" THAT WAS FOUND IN THE DRAPE IS A SLIT THAT WAS CAUSED BY A SHARP OF SOME KIND THAT WAS PLACED IN THE BASIN. BECAUSE THIS APPEARS TO BE RELATED TO MISUSE BY THE CUSTOMER, NO ACTIONS ARE BEING TAKEN AT THIS TIME.
Description of Event or Problem
HOLE IN THE FLUID WARMER DRAPE.