Description of Event or Problem · 1
COMPLAINT RECEIVED REPORTING LEAKAGE PROBLEM WITH ONE (1) SFP3259-S 82" INFUSION /FLUSH ADMIN SET W/2-WAY SC; BONDED 60" SMALLBORE EXTENSION SETS. THE DEVICE SET WAS REMOVED AND REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WERE NO REPORTED ADVERSE PT CONSEQUENCES. ONE USED SFP3259-S DEVICE SET, LOT# 970652 WAS RETURNED TO THE MFR FOR TESTING AND ANALYSIS. THE MFR'S DEVICE/COMPLAINT ANALYSIS IS SUMMARIZED BELOW: FUNCTIONAL/PERFORMANCE TESTS WERE PERFORMED. THE RESULTS CONFIRMED LEAKAGE AT THE SFP3259-S MALE LUER SLIP/STOPCOCK FEMALE LUER BONDED CONNECTION. THE ROOT CAUSE WAS DUE TO A POOR QUALITY BOND. A REVIEW OF THE MFR LOT DATABASE RECORDS FOR LOT# 970652 (MFR DATE 09/2007) SHOWS (B)(4). A CORRECTIVE ACTION REQUEST (CAR) WAS GENERATED. THE CAR ACTIVITIES AND PROCESSES ARE STRUCTURED TO IDENTIFY AND DETERMINE THE SOURCE, SCOPE, PROBABLE CAUSES AND TO IDENTIFY AND IMPLEMENT SOLUTIONS TO ADDRESS THE ISSUES. ALTHOUGH NOT ALWAYS REPEATABLE, THE CAR ENGINEERING ANALYSIS DOCUMENTED THAT IT WAS POSSIBLE FOR THE SETS MALE LUER SLIP TO SLIDE OUT OF THE FEMALE LUER DURING THE BONDING PROCESS. FURTHER TESTING, ANALYSIS AND VALIDATIONS SHOWED THAT BY CHANGING THE MALE LUER SLIP MATERIAL FROM A RIGID PVC TO A SEMI RIGID PVC RESULTED IN A BETTER QUALITY BOND. CURRENT BUILD REFLECTS THIS CHANGE TO THIS SUB ASSEMBLY. THE ONE (1) RETURNED SFP3259-S REFLECTED LOT# 970652 (MFR 09/2007). THIS LOT WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THIS COMPONENT LUER CHANGE.