BALLARD

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 13 FEB 2026 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY RISK ASSESSMENT. THE ULTIMATE RISK IS LOW, AS THAT IS THE HIGHEST RISK OF THE PATIENT/CAREGIVER AND REGULATORY/COMPLIANCE CONSIDERATIONS: PATIENT/CAREGIVER. PERFORMED RISK ASSESSMENT WITH DHFE-06243 "ORAL CARE PRODUCTS HAZARDS ANALYSIS", REVISION 5; THE MOST CLOSELY ASSOCIATED HAZARD IS HZD010-01 HAZARDOUS SITUATION "INADEQUATE SUCTION" WITH A PROBABILITY OF HARM OCCURRING P= (1) IMPROBABLE AND SEVERITY (S)=2-MINOR WHICH IS LOW RISK. THE CALCULATED P1 BASED ON COMPLAINTS AND SALES IN THE PREVIOUS 24 MONTHS IS 0.0002% CORRESPONDING TO IMPROBABLE. THEREFORE, THE PROBABILITY OF HARM OCCURRING (P) REMAINS THE SAME AS THE RMA AND IS DETERMINED TO BE LOW RISK PER REF-20001-C1 REV#2. REGULATORY/ COMPLIANCE. REVIEWED REF-20001-C1 REV#2, AND THERE IS LOW REGULATORY/ COMPLIANCE RISK. BRAND RECOGNITION AND CUSTOMER IMPACT. REVIEWED REF-20001-C1 REV#2, AND THERE IS LOW BRAND RECOGNITION/CUSTOMER IMPACT. DEVICE HISTORY RECORD (DHR) REVIEW. BASED ON THE DEVICE HISTORY RECORD (DHR) REVIEW THERE WERE NO ABNORMAL PROCESSING ISSUES NOTED. ALL PRODUCTS/PACKAGING WERE PRODUCED PER THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND INSPECTIONS. COMPLAINT HISTORY REVIEW THE COMPLAINT HISTORY WAS REVIEWED IN GRAND AVENUE FROM REPORTED DATES JAN/14/2024 THROUGH JAN/14/2026, FOR PART NUMBER 1222 AND FAILURE MODE "CATHETER DOES NOT SUCTION". THERE WERE 4 OTHER COMPLAINTS REPORTED FOR THE SAME ISSUE DURING THE SAME TIMEFRAME. SALES = 2,220,508 EA. CALCULATED OCCURRENCE (P1) = (5 COMPLAINTS / 2,220,508 EA SOLD) X 100 = 0.0002 % OCCURRENCE RANKING = IMPROBABLE.

Description of Event or Problem

IT WAS REPORTED: THAT THE CATHETER SEEMS TO BE OBSTRUCTED AND DOESN'T ALLOW LIQUID TO TRAVEL THROUGH PROPERLY.

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS ALL INFORMATION REASONABLY KNOWN AS OF 13 FEB 2026 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY

Description of Event or Problem

IT WAS REPORTED: THAT THE CATHETER SEEMS TO BE OBSTRUCTED AND DOESN'T ALLOW LIQUID TO TRAVEL THROUGH PROPERLY.