MASK KIT,FIXED VENTURI,ADULT

Additional Manufacturer Narrative

QN# (B)(4). NEW INFORMATION RECEIVED INDICATES THAT THIS WAS NOT A REPORTABLE EVENT, THUS, THE INITIAL MDR, SUBMITTED ON 07/01/2019, WAS SUBMITTED IN ERROR. THE MANUFACTURING FACILITY HAS INDICATED THAT THE 1098 KIT CONTAINS A 28% YELLOW DILUTER; HOWEVER, THE KITS REPORTED IN THE COMPLAINT CONTAINED A COMPONENT FROM ANOTHER KIT, WHICH WAS A 35% YELLOW DILUTER. THE DILUTER WAS NOT LABELED INCORRECTLY, THE ISSUE WAS THAT THE INCORRECT YELLOW DILUTER WAS PLACED IN THE KIT DURING ASSEMBLY. THE SALES REP WAS ALSO CONTACTED AND STATED THAT THE ISSUE WAS FOUND PRIOR TO ANY PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

QN# (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

Description of Event or Problem

THE CUSTOMER HAS INDICATED THAT THE YELLOW DILUTOR IS STAMPED WITH 35% INSTEAD OF 28%. NO PATIENT INVOLVEMENT REPORTED.