BD¿ DEHP FREE INFUSION SET

Additional Manufacturer Narrative

THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. INVESTIGATION RESULTS: SUMMARY: ONE SAMPLE WAS RETURNED TO (B)(4) , LOT NUMBER 2707261, (B)(4) CHECKED THE SAMPLE AND FOUND THERE WAS HAIR BETWEEN Y-CONNECTOR BODY AND SHRINKING FILM. HOUSE SAMPLE INSPECTION: (B)(4) INSPECTED 15 PCS OF HOUSE SAMPLE FOR LOT 2707261, NO FOREIGN MATTER WAS FOUND ON THE SAMPLES. DEVICE HISTORY RECORD REVIEW: (B)(4) CHECKED MANUFACTURING RECORDS INCLUDING RECEIVING INSPECTION REPORT, PROCESS INSPECTION REPORT AND FINISHED PRODUCT TEST REPORT FOR LOT 2707261, NO ABNORMALITY WAS OBSERVED. (B)(4) COMPLAINT RECORD REVIEW: (B)(4) REVIEWED CUSTOMER COMPLAINT RECORD AND THERE IS NO REPEATED SAME ISSUE FROM OTHER CUSTOMER. Y CONNECTOR ASSEMBLY PROCESS - (B)(4) INVESTIGATION THE PROCESS FLOW OF Y CONNECTOR, AND FOUND THE FM (HAIR) BETWEEN Y-CONNECTOR BODY AND SHRINKING FILM WOULD HAVE OCCURRED IN THE MANUAL ASSEMBLY PROCESS OF SHRINKING FILM WITH Y-CONNECTOR BODY & RUBBER CAP. ROOT CAUSE: THE FOREIGN MATTER OF THE COMPLAINT SAMPLE, HAIR, MOST LIKELY OCCURRED IN THE MANUAL ASSEMBLY PROCESS OF SHRINKING FILM WITH Y-CONNECTOR BODY & RUBBER CAP. (B)(4) INVESTIGATED AND CONCLUDED THAT DUE TO INSUFFICIENT CLEANROOM PROTOCOL CLEANLINESS / DRESSING STANDARDS, PRODUCTION WORKERS IN THE ASSEMBLY LINE MIGHT HAVE INDUCED FOREIGN MATTER (HAIR) INTO THE PRODUCTS UNKNOWINGLY. (B)(4) HAVE ALSO REVIEWED RECEIVING INSPECTION REPORT AND I.V SET MANUFACTURING PROCESS ABOUT THIS CASE BUT, THERE WAS NO ABNORMAL ISSUE. CORRECTIVE ACTIONS: (B)(4) HAD QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR I.V SET ASSEMBLY LINE WORKERS AND QUALITY INSPECTORS. (B)(4) IMPLEMENT TIGHTENED PRODUCT & PROCESS MONITORING AND STRENGTHENING QUALITY INSPECTION FOR Y-CONNECTOR INSPECTION AND I.V SET PROCESS INSPECTION. (B)(4) CONDUCT CLEANING MANUFACTURING LINE, INSPECTION TABLE AND ASSEMBLY TABLE 3 TIME A DAY, BEFORE START WORK, BEFORE LUNCH AND AFTER FINISH WORK, ACCORDING TO WORKING PLACE CLEAN PROCEDURE. (B)(4) ENHANCE CLEANROOM CLOTHES REGULATION FOR ALL WORKERS (ANTI-DUST INNER CAP WITH ANTI-DUST CAP) TO PREVENT FM(HAIR) IN THE I.V SET ASSEMBLY PROCESS. THE INNER CAP COULD CATCH HAIR INSIDE THE CAP SO, HAIR DROP COULD BE PREVENTED.

Description of Event or Problem

IT WAS REPORTED THAT FOREIGN MATTER "HAIR" WAS FOUND IN A BD¿ DEHP FREE INFUSION SET, SPECIFICALLY IN THE GAP BETWEEN Y-PORT CONNECTIONS. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.