12.5 IN (32 CM) Q2 T-EXTENSION SET W/ 3 Q2 CHECKVALVE T-SITES

Additional Manufacturer Narrative

NO SAMPLE WAS RETURNED FOR INVESTIGATION. THREE ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER VIA PHONE AND EMAIL, BUT NO RESPONSE WAS RECEIVED. NO PHOTOS OR VIDEOS OF THE FAILURE WERE PROVIDED. THE CUSTOMER WAS PROVIDED WITH A DRAWING OF THE PRODUCT AND ASKED TO INDICATE WHERE THE FAILURE WAS OBSERVED, BUT NO RESPONSE WAS RECEIVED. WITHOUT THE SAMPLE, THE COMPLAINT CONDITION COULD NOT BE CONFIRMED AS MANUFACTURING RELATED. THE DHR REVIEW SHOWED THERE WERE NO QUALITY OR MANUFACTURING ISSUES AND NO COMPLAINTS HAVE BEEN RECEIVED FOR LOT 74845 REPORTED BY THE CUSTOMER. MANUFACTURING RECORDS SHOW THAT THE PART NUMBER ASSOCIATED WITH LOT 74845 IS 95702. HOWEVER, THE CUSTOMER REPORTED PART NUMBER 95710 AS THE DEVICE WITH WHICH THEY ENCOUNTERED ISSUES. THERE IS THEREFORE A DISCREPANCY BETWEEN THE LOT NUMBER AND PART NUMBER REPORTED BY THE CUSTOMER. QUEST MEDICAL WILL CONTINUE TO MONITOR COMPLAINTS FOR TRENDS.

Description of Event or Problem

MEDSUN REPORT NUMBER (B)(4) WAS RECEIVED FROM FDA ON MARCH17, 2025. THE REPORT STATES THAT THE IV EXTENSION SET WAS CONNECTED TO THE PATIENT'S PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] LINE WITH MULTIPLE DRIPS INFUSING, TWO END PORTS DISCONNECTED SPONTANEOUSLY FROM THE REST OF THE EXTENSION SET AND BLOOD WAS FOUND IN BED BY EKG TECH. THE REPORT DID NOT INDICATE THAT THERE WERE PATIENT COMPLICATIONS FROM THE ALLEGED ISSUE.

Additional Manufacturer Narrative

PER INFORMATION RECEIVED FROM THE MEDSUN REPORT, THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR INVESTIGATION. QUEST MEDICAL WILL REVIEW MANUFACTURING RECORDS AND A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE REVIEW IS COMPLETE.