HUDSON MASK KIT,FIXED VENTURI,ADULT,INTL

Additional Manufacturer Narrative

(B)(4). INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT OR A PICTURE OF THE ALLEGED DEFECT WAS NOT PROVIDED AT THE TIME OF THIS REPORT. IT IS UNCLEAR IF THE DEVICE IS AVAILABLE FOR INVESTIGATION. TELEFLEX HAS REQUESTED THIS INFORMATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. TO PERFORM A PROPER AND THOROUGH INVESTIGATION TO CONFIRM THE ALLEGED DEFECT REPORTED, DETERMINE THE ROOT CAUSE AND ESTABLISH ANY CORRESPONDING CORRECTIVE ACTIONS, IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED IN THIS COMPLAINT. CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION PROVIDED. ROOT CAUSE IS UNKNOWN. NO CORRECTIVE ACTIONS CAN BE ESTABLISHED. IF THE SAMPLE BECOMES AVAILABLE THIS REPORT WILL BE UPDATED WITH THE EVALUATION RESULTS.

Description of Event or Problem

CUSTOMER COMPLAINT ALLEGES THAT INDIVIDUAL ITEMS HAVE NO LOT NUMBERS OR FLOW RATES IDENTIFIED ON THE PLAIN UNIT PACKAGING ALTHOUGH THESE DETAILS ARE PROVIDED ON THE BOX QUANTITY?

Additional Manufacturer Narrative

(B)(4). THE CUSTOMER HAS REACHED OUT TO TELEFLEX TO FURTHER EXPLAIN THAT THEY DO NOT HAVE A COMPLAINT, BUT RATHER QUESTIONS RELATING TO CHARACTERISTICS OF THE TELEFLEX PRODUCT COMPARED TO ALTERNATIVE DEVICES IN THE MARKETPLACE. AS THIS IS NOT A COMPLAINT, THE COMPLAINT THAT WAS OPENED WILL BE VOIDED.

Description of Event or Problem

CUSTOMER COMPLAINT ALLEGES THAT INDIVIDUAL ITEMS HAVE NO LOT NUMBERS OR FLOW RATES IDENTIFIED ON THE PLAIN UNIT PACKAGING ALTHOUGH THESE DETAILS ARE PROVIDED ON THE BOX QUANTITY?.