ORS-300N WARMER DRAPE
Received May 17, 2018 · Event occurred Apr 17, 2018
Report 8043817-2018-00018 · MDR key 7523908
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-300NLot number
D172599
Product problems
- Hole In Material
- Hole In Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
NO SAMPLE WAS RECEIVED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED. THIS LOT HAD (B)(4) PIECES THAT WERE MANUFACTURED FROM 09/18/17 TO 09/19/17. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS BASED ON THE DEVICE HISTORY RECORD, THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. MELTS, THOUGH UNCOMMON, CAN OCCUR WHEN THE WARMER IS NOT DRAPED PROPERLY, NOT TURNED OFF BY USING THE POWER BUTTON, AND/OR THERE IS INSUFFICIENT FLUID IN THE WARMER BASIN, CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS. NO FURTHER ACTIONS ARE BEING TAKEN AT THIS TIME.
Description of Event or Problem
CUSTOMER REPORTS "WE DISCOVERED A HOLE IN THE WARMER DRAPE ((B)(4)) PROVIDED IN A CRANIOTOMY PACK TODAY" NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.THIS DRAPE IS SOLD NON-STERILE TO A KIT PACKER TO BE INCLUDED IN A PROCEDURE KIT AND STERILIZED BEFORE USE.