SUCT W/FUNNEL CONN 14FR BX100

Additional Manufacturer Narrative

THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION.  IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.  AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.

Description of Event or Problem

CUSTOMER REPORTS: THE CATHETERS LEAK BETWEEN THE ATTACHMENT PART (GREEN CONE AND TUBE). THIS CAUSED GASTRIC JUICE TO LEAK INTO THE AREA OF THE PATIENT'S FACE. FURTHERMORE, THE SUCTION POWER WAS INSUFFICIENT AS A RESULT. THIS LEAKAGE WAS OBSERVED OR REPORTED 3 TIMES IN THE LAST FEW DAYS. ADDITIONAL INFORMATION WAS RECEIVED ON 7/21/21 THAT THE GREEN CONNECTOR WAS DISCONNECTED FROM THE TRANSPARENT TUBE.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) REVIEW SHOWED THAT ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS OF LOT 20J185FHX. ONE (1) 14FR SUCTION CATHETER WITH FUNNEL CONNECTOR SAMPLE WAS RETURNED FOR EVALUATION. AA VISUAL INSPECTION OF THE UNIT WAS COMPLETED BY THE EXTRUSION AND MOLDING MANAGER AND THE QUALITY ENGINEER. THERE WERE NO OBVIOUS VISUAL DEFECTS OBSERVED ON THE SUCTION CATHETER. A QUALITY INSPECTION WAS COMPLETED ON THE UNIT IN LINE WITH IN-PROCESS REQUIREMENTS OUTLINED IN THE PROCEDURE. THE BONDED JUNCTION BETWEEN THE CATHETER SHAFT AND FUNNEL CONNECTOR WAS TESTED PER THE JUNCTION PULL TEST WHERE THE RETURNED UNIT WAS SUBJECTED TO A STATIC WEIGHT TEST AND THE UNIT PASSED THIS STATIC WEIGHT TEST. THIS TEST HAS CONFIRMED THAT THE UNIT WAS MANUFACTURED AS REQUIRED AND THERE WAS GLUE PRESENT TO FORM THE BOND BETWEEN THE SHAFT AND FUNNEL. THE FUNNEL OF THE RETURNED UNIT WAS THEN SLICED OPEN TO REVIEW THE TUBE DIMENSIONS AT THE FUNNEL. THE OUTER DIAMETER OF THE TUBE WAS INSPECTED, AND THE RESULTS WERE WITHIN THE OD SPECIFICATION. THIS CONFIRMS THE TUBING DIMENSIONS WERE MANUFACTURED AS REQUIRED. AS THE SAMPLE PASSED ALL REQUIRED TESTING, THE INVESTIGATION WAS UNABLE TO CONFIRM THE REPORTED ISSUE THEREFORE AT THIS TIME A DEFINITIVE ROOT CAUSE FOR THE REPORTED ISSUE CANNOT BE DETERMINED. BASED ON ALL AVAILABLE INFORMATION, A CORRECTIVE AND PREVENTATIVE ACTION WILL NOT BE INITIATED AT THIS TIME. HOWEVER, WE WILL CONTINUE TO MONITOR THE PROCESS FOR ANY ADVERSE TRENDS THAT REQUIRE IMMEDIATE ATTENTION.