WARMER DRAPE

Additional Manufacturer Narrative

THE DHR WAS REVIEWED AND IT WAS SHOWN THAT - ORS 320, LOT D 151181 HAD (B)(4) PIECES MANUFACTURED ON 04/28/2015. THERE WERE NO DEFECTS IN THE PROCESSES, PACKAGING OR FINAL INSPECTION (NOTE: THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS). SINCE NO DEVICE WAS RETURNED FOR ANALYSIS, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.

Description of Event or Problem

CUSTOMER WAS REPORTING THAT THE DRAPE SLUSH WARMER, ORS - 320, 44 X 66 THAT HELD SALINE/ANTIBIOTIC MIXTURE NOTED TO BE WET ON THE BOTTOM AFTER COMPLETION OF CASE. UPON INSPECTION TWO HOLES WERE NOTED ON DRAPE. AN ADDITIONAL ANTIBIOTIC WAS PROVIDED TO PATIENT BY PHYSICIAN.

Additional Manufacturer Narrative

THE DHR WAS REVIEWED AND IT WAS SHOWN THAT ORS -320 LOT D151181 HAD (B)(4) PIECES AND WAS MANUFACTURED ON 04/28/2015. THERE WERE NO DEFECTS IN THE PROCESSES, PACKAGING OR FINAL INSPECTION (NOTE: THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS). SINCE NO DEVICE WAS RETURNED FOR ANALYSIS, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED. FOLLOW UP #1: LOT 1037253 WAS REPORTED FOR THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO THE NON STERILE LOTS FROM MICROTEK: D1518181, D151611, D151941, D151331, D152221, D151451, D151381, D151391, D151351, D152161, D151601. THE DHR WAS REVIEWED FOR LOT D151181. THIS LOT HAD (B)(4) PCS AND WAS MANUFACTURED ON 04/28/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. THE DHR WAS REVIEWED FOR LOT D151451. THIS LOT HAD (B)(4) PCS AND WAS MANUFACTURED ON 05/25/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. THE DHR WAS REVIEWED FOR LOT D151331. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 05/13/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. THE DHR WAS REVIEWED FOR LOT D151381. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 05/19/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. THE DHR WAS REVIEWED FOR LOT D151391. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 05/20/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. THE DHR WAS REVIEWED FOR LOT D151611. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 06/10/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. THE DHR WAS REVIEWED FOR LOT D151941. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 07/14/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. THE DHR WAS REVIEWED FOR LOT D151351. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 05/18/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. THE DHR WAS REVIEWED FOR LOT D152161. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 08/05/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D152221. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 08/11/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. LOT D151501 WAS NOT ASSIGNED FOR PRODUCT ORS-320N. BASED ON THE DHR REVIEW THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. DUE TO SAMPLE NOT BEING REVIEWED THE NON CONFORMITY COULD NOT BE PHYSICALLY CONFIRMED.

Description of Event or Problem

CUSTOMER WAS REPORTING THAT THE DRAPE SLUSH WARMER, ORS-320 22X66 THAT HELD SALINE/ANTIBIOTIC MIXTURE NOTED TO BE WET ON THE BOTTOM AFTER COMPLETION OF CASE. UPON INSPECTION TWO HOLES WERE NOTED ON THE DRAPE. AN ADDITIONAL ANTIBIOTIC WAS PROVIDED TO PATIENT BY PHYSICIAN.