ORS-300N WARMER DRAPE
Received Mar 14, 2018 · Event occurred Feb 14, 2018
Report 8043817-2018-00008 · MDR key 7337562
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-300NLot number
D171351
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
ORS-300N IS A NON STERILE PART WHICH IS SOLD TO A KIT PACKER TO BE USED AS A COMPONENT IN CUSTOM STERILE KITS. THIS COMPLAINT WAS ORIGINALLY REPORTED BY THE END USER TO THE KIT PACKER. THE DHR WAS REVIEWED AND IT WAS NOTICED THAT THIS LOT HAD 200 CASES THAT WERE MANUFACTURED FROM 5/15/17 TO 5/19/17. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. BASED ON THE DEVICE HISTORY RECORD REVIEW, THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. AT THE TIME OF THIS REPORT, THE DEVICE HAD NOT BEEN RETURNED FOR EVALUATION. AS NO DEVICE WAS AVAILABLE FOR EVALUATION, THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
HOLE IN WARMER DRAPE. WARMER DRAPE ALLOWING FLUID TO GO UNDERNEATH INTO WARMER - LOOKS LIKE PIN HOLE. NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.