INTRATEMP THERMABASIN DRAPE
Received Jan 26, 2018
Report 3013401749-2018-00001 · MDR key 7222874
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Medical, Inc.Model number
ITB100Lot number
77263
Product problems
- Crack
- Crack
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
NO SAMPLE WAS RECEIVED FOR EVALUATION. THE INVESTIGATION FOR THIS COMPLAINT IS PENDING A RESPONSE FROM THE SUPPLIER. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS IS REPORT 1 OF 2.
Description of Event or Problem
THIS IS THE 3RD PRODUCT DEFECT WITHIN THE LAST WEEK; 2 OF WHICH WERE CRACKS IN THE BOTTOM OF THE DRAPE. OF NOTE, THE 2 BASINS THAT HAD CRACKS WERE USED IN THE SAME WARMER. NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.
Additional Manufacturer Narrative
NO SAMPLE WAS RECEIVED FOR EVALUATION. THE INVESTIGATION FOR THIS COMPLAINT IS PENDING A RESPONSE FROM THE SUPPLIER. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS IS REPORT 1 OF 2. FOLLOW UP 1: THE DHR WAS RECEIVED FROM THE SUPPLIER ON (B)(6) 2018. NO SIMILAR ISSUES WERE REPORTED ON THE DHR. IT WAS NOTED THAT THE BASIN IS PROCESSED BY INJECTED MOLDING. SINCE SAMPLES OF THE REPORTED DEFECT AND CORRESPONDING PACKAGING WERE UNABLE TO BE RETURNED, THE COMPLAINT COULD NOT BE CONFIRMED AND A THOROUGH ROOT CAUSE INVESTIGATION COULD NOT BE CONDUCTED. NO FURTHER ACTIONS ARE BEING TAKEN AT THIS TIME.
Description of Event or Problem
THIS IS THE 3RD PRODUCT DEFECT WITHIN THE LAST WEEK; 2 OF WHICH WERE CRACKS IN THE BOTTOM OF THE DRAPE. OF NOTE, THE 2 BASINS THAT HAD CRACKS WERE USED IN THE SAME WARMER. NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.