SURGUARD2 SAFETY HYPODERMIC NEEDLE

Additional Manufacturer Narrative

A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED . A2: AGE. REQUESTED, NOT PROVIDED . A3A:SEX. REQUESTED, NOT PROVIDED . A3B: GENDER REQUESTED, NOT PROVIDED . A4: WEIGHT: REQUESTED, NOT PROVIDED . A5: ETHNICITY REQUESTED, NOT PROVIDED . A6: RACE REQUESTED, NOT PROVIDED . D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E1: EMAIL ADDRESS: REQUESTED, NOT PROVIDED. E1: ZIP CODE: REQUESTED, NOT PROVIDED. E3: OCCUPATION: QA MEDICAL DEVICE SENIOR SPECIALIST. WE WERE UNABLE TO DETERMINE THE DETAILS OF THE ACTUAL CONDITION OF THE SAMPLE AS IT WAS NOT AVAILABLE FOR EVALUATION. RETENTION SAMPLES WERE VISUALLY INSPECTED AND FOUND TO BE FREE OF ANY DAMAGE OR IRREGULARITIES ON THE SHEATH AND COLLAR.SHEATH ACTIVATION AND COMPONENT FIT TEST WERE PERFORMED ON THE SAMPLES, AND ALL PASSED. THERE WAS NO ISSUED NONCONFORMITY REPORT RELATED TO HUMAN ERROR DURING LOT PRODUCTION. THERE ARE NO NONCONFORMITIES IN THE ASSEMBLED NEEDLE LOTS SUPPLIED DURING PRODUCTION. DURING THE COLLAR ASSEMBLY PROCESS, THE HUB FIT IS LOOSENED FROM THE PROTECTOR BEFORE PLACING THE NEEDLE INTO THE COLLAR. BEFORE PROCEEDING TO THE NEXT PROCESS, THE HUB, CANNULA, AND COLLAR ARE PRESSED INTO THE PROTECTOR, WHEREIN A PHOTOELECTRIC SENSOR DETECTS IF THE HEIGHT OF THE PROTECTOR IS CORRECT. OUR SAFETY NEEDLE FEATURES A HINGED SAFETY SHEATH ATTACHED TO THE NEEDLE HUB. THE SAFETY SHEATH CONTAINS A LOCKING MECHANISM THAT IS ACTIVATED WHEN MANUALLY PRESSED OVER THE NEEDLE IMMEDIATELY AFTER USE AND JUST BEFORE DISPOSAL TO MINIMIZE THE POSSIBILITY OF SHARP INJURY. THE SG2 SAFETY SHEATH IS ACTIVATED WITH A ONE-HANDED OPERATION BY PRESSING THE SHEATH ON A HARD SURFACE WITH FIRM AND QUICK MOTION. AN AUDIBLE AND/OR TACTILE "CLICK" INDICATES ACTIVATION, WHICH CAN ALSO BE VISUALLY CONFIRMED. AN INITIAL PRODUCT INSPECTION CHECK (IPIC) IS PERFORMED BEFORE MASS PRODUCTION, DURING RAW MATERIAL CHANGE, MOLD MAINTENANCE, PLANT SHUTDOWN, CAVITY CLOSURE, AND MOLD/PRODUCT TYPE CHANGE. ANY MOLDING DEFECTS THAT MAY AFFECT PRODUCT FUNCTION ARE PART OF THE INSPECTION ITEM. WE ALSO HAVE A VISUAL IN-PROCESS AND PRODUCT CONFIRMATION INSPECTION TO ENSURE THAT THE MOLDED PARTS ARE IN GOOD CONDITION. VISUAL IN-PROCESS INSPECTIONS ARE CONDUCTED DURING THE MANUFACTURING PROCESS TO DETECT ABNORMALITIES ON THE PRODUCT THAT MAY CAUSE ISSUES DURING SHEATH ACTIVATION. THE CRITICAL LOCKING PART OF THE SG2 PRODUCT IS CHECKED FOR DEFECTS SUCH AS SHEATH COLLAR FITTING, AND OVER- OR UNDER-INSERTION OF THE COLLAR INTO THE HUB. WE HAVE FUNCTIONAL TESTS CONDUCTED TO CONFIRM THAT OUR PRODUCTS ARE FREE OF DEFECTS THAT WOULD LEAD TO DIFFICULTY OR FAILURE OF DEVICE ACTIVATION. WE PERFORM SAFETY SHEATH ACTIVATION DURING SG ASSEMBLY INSPECTION AND OUTGOING INSPECTION OF FINISHED PRODUCTS, WHERE THE CANNULA SHOULD BE CAPTURED UNDER THE SHEATH'S TOOTH. DURING THE COMPONENT FIT TEST, WE ALSO CHECK THAT THE SHEATH LUGS ARE SECURELY ATTACHED TO THE COLLAR EAR. BEFORE SHIPMENT, QC CONDUCTS OUTGOING INSPECTIONS TO CHECK THE OVERALL CONDITION OF THE PRODUCTS. THE COLLAR IS MANUFACTURED IN-HOUSE WITH VALIDATED TPC MOLDING MACHINES. THERE WERE NO NONCONFORMANCE REPORTS ISSUED FOR THE SUPPLIED MOLDED PART LOTS. OUR SAFETY SHEATH HAS UNDERGONE INCOMING INSPECTION, WHICH INCLUDES VISUAL INSPECTION, DIMENSIONAL INSPECTION, AND VERIFICATION OF THE SUPPLIER'S CERTIFICATE. FROM THE PREVIOUS TWO FISCAL YEARS TO THE PRESENT, WE RECEIVED A TOTAL OF 16 COMPLAINTS FOR THE SPECIFIC ITEM CODE. THE CAUSE OF THESE COMPLAINTS WAS NOT IDENTIFIED AS BEING RELATED TO OUR PRODUCT OR THE MANUFACTURING PROCESS. RETENTION SAMPLES OF 25G NEEDLES WERE SIMULATED. THE SAMPLES WERE ACTIVATED USING THREE METHODS: FINGER, THUMB, AND HARD SURFACE ACTIVATION. THE SAFETY SHEATH WAS SUCCESSFULLY ACTIVATED ON THE SAMPLES AND NO IRREGULARITIES WERE ENCOUNTERED. THE CANNULA WAS CAPTURED UNDER THE SHEATH TOOTH. BASED ON THE RESULTS OF OUR INVESTIGATION, THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE IDENTIFIED TO BE RELATED TO OUR PRODUCT OR MANUFACTURING PROCESS. THE LOT HISTORY FILE SHOWED NO NON-CONFORMITY OR ANY RELATED TROUBLES THAT WOULD AFFECT THE PRODUCT QUALITY. THE RETENTION SAMPLES WERE INSPECTED AND CONFIRMED TO BE FREE FROM DEFECTS THAT WOULD AFFECT THE ACTIVATION OF THE SAFETY SHEATH AND PASSED THE FUNCTIONAL TEST. THE SAFETY SHEATH WAS SUCCESSFULLY ACTIVATED AND THE CANNULA WAS CAPTURED UNDER THE SHEATH TOOTH DURING THE SIMULATION. WE PERFORM ROUTINE INSPECTIONS TO CONFIRM THE PERFORMANCE OF THE DEVICE THROUGHOUT ITS MANUFACTURING PROCESS, WHICH INCLUDES VISUAL AND FUNCTIONAL CHECKS. WE HAVE ROUTINE INSPECTIONS TO CHECK THE CONDITION OF THE PRODUCTS. THE COMPONENTS THAT ARE CRITICAL TO THE PRODUCT'S SAFETY ACTIVATION ARE CHECKED TO ENSURE THAT NO DEFECTS OCCUR THAT COULD RESULT IN SHEATH ACTIVATION ISSUES. WE RECOMMEND FOLLOWING THE INSTRUCTIONS FOR USE (IFU) FOR PROPER USE OF THE SG2 NEEDLE, WHICH INCLUDES CAUTION, PRECAUTIONS, AND WARNINGS TO AVOID PROBLEMS DURING SHEATH ACTIVATION. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF TERUMO (PHILIPPINES) CORPORATION (MANUFACTURER) REGISTRATION NO. 3003902955.

Description of Event or Problem

TERUMO RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE SAFETY SLIDE DID NOT ENGAGE POST ADMINISTRATION.