ORS-100 FLUID WARMER DRAPE
Received Apr 4, 2018
Report 8043817-2018-00009 · MDR key 7397224
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-100Lot number
SEE H10
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 AVAILABLE FOR EVALUATION. MULTIPLE LOTS WERE PROVIDED BY THE END USER: D171869, D172279, D171859, D172029, D172399. THE DHRS WERE REVIEWED AND IT WAS NOTICED THAT: D172279: THIS LOT HAD (B)(4) PCS THAT WERE MANUFACTURED ON 08/15/2017. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. D171859: THIS LOT HAD (B)(4) PCS THAT WERE MANUFACTURED FROM 07/06/2017 TO 07/07/2017. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. D172029: THIS LOT HAD (B)(4) PCS THAT WERE MANUFACTURED ON 07/21/2017. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. D172399: THIS LOT HAD (B)(4) PCS THAT WERE MANUFACTURED FROM 08/28/2017 TO 08/29/2017. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. D171869: THIS LOT HAD (B)(4) PCS THAT WERE MANUFACTURED FROM 07/07/2017 TO 07/10/2017. 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. THE NON CONFORMITY COULD NOT BE CONFIRMED SINCE NO SAMPLE WAS RETURNED FOR REVIEW. BECAUSE NO SAMPLE WAS RETURNED THE NON CONFORMITY COULD NOT BE CONFIRMED AND THE ROOT CAUSE FOR THIS INVESTIGATION IS UNDETERMINED. NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME. IF ADDITIONAL INFORMATION OR SAMPLE BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
CUSTOMER COMPLAINED THAT DRAPE HAD PINHOLE PRICK IN IT THAT WAS FOUND AFTER THE CASE ENDED. DRAPE CAME FROM ONE OF LOT NUMBERS ABOVE, BUT THEY THREW AWAY THE DRAPE ITSELF. NEED AN ANALYSIS OF LOT NUMBERS TO MAKE SURE THERE'S AREN'T COMPROMISED. THE OR NOTED "THE PATIENT HAD A POST OPERATIVE INFECTION THAT WAS DUE TO A FEEDING TUBE AND UNLIKELY DUE TO THE PRODUCT DEFICIENCY."
Additional Manufacturer Narrative
NO SAMPLE WAS AVAILABLE FOR EVALUATION. MULTIPLE LOTS WERE PROVIDED BY THE END USER: D171869, D172279, D171859, D172029, D172399. THE DHRS WERE REVIEWED AND IT WAS NOTICED THAT: D172279: THIS LOT HAD (B)(4) PCS THAT WERE MANUFACTURED ON 08/15/17. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. D171859: THIS LOT HAD (B)(4) PCS THAT WERE MANUFACTURED FROM 07/06/17 TO 07/07/17. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. D172029: THIS LOT HAD (B)(4) PCS THAT WERE MANUFACTURED ON 07/21/17. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. D172399: THIS LOT HAD (B)(4) PCS THAT WERE MANUFACTURED FROM 08/28/17 TO 08/29/17. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. D171869: THIS LOT HAD (B)(4) PCS THAT WERE MANUFACTURED FROM 07/07/17 TO 07/10/17. 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. THE NON CONFORMITY COULD NOT BE CONFIRMED SINCE NO SAMPLE WAS RETURNED FOR REVIEW. BECAUSE NO SAMPLE WAS RETURNED THE NON CONFORMITY COULD NOT BE CONFIRMED AND THE ROOT CAUSE FOR THIS INVESTIGATION IS UNDETERMINED. NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME. IF ADDITIONAL INFORMATION OR SAMPLE BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. FOLLOW UP 1: SAMPLES RECEIVED FOR EVALUATION. ONLY LOTS D172029, D172279 AND D172399 WERE RETURNED. ONE UNOPENED DRAPE FROM EACH LOT WAS TESTED, DRAPED OVER A WARMER WITH WATER AND NO LEAKS OR HOLES WERE FOUND. BASED ON THE SAMPLE REVIEW THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL PROCESS OR MATERIAL ISSUE. BECAUSE THE UNOPENED SAMPLES RETURNED DIDN'T HAVE ANY HOLES AND THE SAMPLE IN QUESTION WAS NOT RETURNED, THE NON CONFORMITY COULD NOT BE CONFIRMED AND THE ROOT CAUSE FOR THIS INVESTIGATION IS UNDETERMINED. NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME.
Description of Event or Problem
CUSTOMER COMPLAINED THAT DRAPE HAD PINHOLE PRICK IN IT THAT WAS FOUND AFTER THE CASE ENDED. DRAPE CAME FROM ONE OF LOT NUMBERS ABOVE, BUT THEY THREW AWAY THE DRAPE ITSELF. NEED AN ANALYSIS OF LOT NUMBERS TO MAKE SURE THERE'S AREN'T COMPROMISED. THE OR NOTED "THE PATIENT HAD A POST OPERATIVE INFECTION THAT WAS DUE TO A FEEDING TUBE AND UNLIKELY DUE TO THE PRODUCT DEFICIENCY."