SYRINGE WITH SAFETY HYPODERMIC NEEDLE (MCKESSON PRIVATE LABEL)

Description of Event or Problem

TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING HARD SURFACE ACTIVATION OF THE NEEDLE SAFETY SHEATH, DUE TO THIN WALLS, THE NEEDLE WAS BENDING.

Additional Manufacturer Narrative

A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3A: SEX: REQUESTED, NOT PROVIDED. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUETED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. B3: DATE OF EVENT: REQUESTED, NOT PROVIDED. D4: POTENTIAL LOT NUMBER: 250514F, 250614F, 250630F. D4: POTENTIAL EXPIRATION DATE: 30-APR-2030, 31-MAY-2030, 31-MAY-2030. D4: POTENTIAL UDI: ((B)(4). D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: PURCHASING MANAGER. H4: POTENTIAL DEVICE MANUFACTURE DATE: 14-MAY-2025, 14-JUN-2025, 30-JUN-2025. THE ACTUAL SAMPLE WAS NOT AVAILABLE FOR EVALUATION. INSTEAD, A REFERENCE PHOTO WAS RECEIVED. THE CANNULA WAS BENT OUT OF THE SHEATH, AND THE COLLAR WING WAS NOT ACTIVATED. RETENTION SAMPLES WERE VISUALLY INSPECTED AND FOUND TO BE FREE OF ANY BENT CANNULA AND DAMAGE, OR IRREGULARITIES ON THE SHEATH AND COLLAR. THERE WAS NO ISSUED NONCONFORMITY REPORT RELATED TO HUMAN ERROR DURING THE PRODUCTION OF THE LOT. THERE ARE NO NONCONFORMITIES IN THE ASSEMBLED NEEDLE LOT SUPPLIED DURING PRODUCTION. THE NEEDLES WERE MANUFACTURED AT NEEDLE ASSEMBLY MACHINE 1, WHICH HAS AN INSPECTION SYSTEM THAT DETECTS TILTED AND BENT CANNULAS. DUMMY CHECKING IS CONDUCTED FOR EVERY TYPE OF CHANGE, END OF THE LOT, AND MACHINE ADJUSTMENT/TROUBLESHOOTING/REPLACEMENT OF PARTS TO ENSURE THE ACCURACY OF THE INSPECTION SYSTEM. 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 SYRINGE FEATURES A HINGED SAFETY SHEATH ATTACHED TO THE NEEDLE HUB. THE SAFETY SHEATH CONTAINS TWO LOCKING MECHANISMS, THE SHEATH TOOTH-CANNULA AND SHEATH WINGS-COLLAR, WHICH ARE SIMULTANEOUSLY ACTIVATED WHEN MANUALLY PRESSED OVER THE NEEDLE IMMEDIATELY AFTER USE AND JUST BEFORE DISPOSAL TO MINIMIZE THE POSSIBILITY OF SHARPS INJURY. OUR PRODUCT HAS AN ALLOWABLE TILTING OF THE NEEDLE OF NOT MORE THAN 2°. TILTED CANNULAS ARE ONE OF THE CHECK ITEMS IN THE HOURLY IN-PROCESS INSPECTION DURING NEEDLE ASSEMBLY. THE COLLAR AND SHEATH UNDERGO AN INITIAL PRODUCT INSPECTION CHECK (IPIC) 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 COLLAR AND SHEATH 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 SG3 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 PRODUCT'S INSTRUCTIONS FOR USE (IFU) PROVIDE DETAILED INSTRUCTIONS FOR USING THE SG3 SAFETY SYRINGE DEVICE, INCLUDING WARNINGS TO PREVENT NEEDLE STICKS. OUR CANNULA IS A SUPPLIED RAW MATERIAL THAT COMPLIES WITH ISO 9626, PARTICULARLY IN TERMS OF DIMENSION, WALL THICKNESS, STIFFNESS, AND BREAKAGE. IT UNDERGOES 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 116 COMPLAINTS FOR THE SAME ISSUE AFFECTING SG3 25G DEVICES. THE CAUSE OF THESE COMPLAINTS WAS NOT IDENTIFIED AS BEING RELATED TO OUR PRODUCT OR THE MANUFACTURING PROCESS. THE RETENTION SAMPLES WERE INJECTED INTO THE DUMMY ARM'S VEINS AND A RUBBER CORK TO SIMULATE INTRAVENOUS AND INTRAMUSCULAR INJECTIONS PRIOR TO SAFETY ACTIVATION. THE SAFETY SHEATH WAS SUCCESSFULLY ACTIVATED ON THE SAMPLES; THE NEEDLE DID NOT BEND OUT OF THE SHEATH, AND NO DIFFICULTIES WERE ENCOUNTERED. IN THE NEXT SIMULATION, THE NEEDLE WAS FORCEFULLY INJECTED INTO THE CORK, CAUSING IT TO SLIGHTLY BEND. DESPITE BEING BENT, THE SHEATH-TOOTH WAS ABLE TO COMPLETELY CAPTURE THE CANNULA, AND THE COLLAR WING WAS FULLY LOCKED ON THE SHEATH, INDICATING THAT THE ACTIVATION WAS SUCCESSFUL. BASED ON THE RESULTS OF OUR INVESTIGATION, THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE IDENTIFIED AS RELATED TO OUR PRODUCT OR MANUFACTURING PROCESS. THE PHOTO PROVIDED SHOWED THE NEEDLE BENDING OUT OF THE SHEATH AFTER ACTIVATION. HOWEVER, THE LOT HISTORY FILE SHOWED NO RELATED NON-CONFORMITIES OR ANY TROUBLES THAT COULD HAVE LED TO THE COMPLAINT. THE RETENTION SAMPLES WERE INSPECTED AND CONFIRMED TO BE FREE FROM DEFECTS THAT WOULD AFFECT THE ACTIVATION OF THE SAFETY SHEATH. WE WERE UNABLE TO RECREATE THE DEVICE FAILURE WHEN WE PERFORMED THE SIMULATION. ALTHOUGH THE NEEDLE WAS FORCEFULLY INJECTED AND WAS SLIGHTLY BENT, THERE WAS STILL SUCCESSFUL ACTIVATION. THE CANNULA DID NOT BEND OUT OF THE SHEATH. 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 SG3 SYRINGE, 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.