ORS-320 SLUSH WARMER DISC DRAPE
Received May 1, 2018 · Event occurred Feb 14, 2018
Report 8043817-2018-00014 · MDR key 7476239
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-320Lot number
D172361
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
NUMEROUS ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER TO OBTAIN THE SAMPLE BUT A RESPONSE WAS NOT RECEIVED. THE DHR WAS REVIEWED AND IT WAS CONFIRMED THAT LOT D172361 HAD (B)(4) CASES THAT WERE MANUFACTURED FROM 08/24/17 TO 08/26/17. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTION. BASED ON THE DEVICE HISTORY RECORD THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. SINCE NO SAMPLE WAS PROVIDED THE NON CONFORMITY COULD NOT BE CONFIRMED. NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
DURING CASE, CIRCULATOR NOTICED SALINE IN WARMER NOT CONTAINED IN STERILE DRAPE. NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.