SOL-MILLENNIUM MEDICAL HK LIMITED

Additional Manufacturer Narrative

RETAINED SAMPLE RETESTING: ON DECEMBER 19, 2024, 10 PIECES OF THE ABOVE SAMPLE PRODUCTS WITH BATCH NUMBER: 02211022 SPECIFICATION: 22G×3.5" (0.7MM×89MM) WERE EXTRACTED FOR RELEVANT TESTING AS FOLLOWS: 1. 10 NEEDLES WERE SELECTED FOR INSPECTION OF THE APPEARANCE OF THE NEEDLE TUBES. AFTER VISUAL OBSERVATION OF THE NEEDLE TUBES BY 50 TIMES MAGNIFICATION AND INVESTIGATION, IT WAS FOUND THAT THE PRODUCT COULD NOT BE ASSEMBLED DUE TO THE SOLID CORE NEEDLE IN THE MIDDLE OF THE NEEDLE TUBE OF THE PRODUCT STRUCTURE AND THE SOLID CORE NEEDLE TUBE CONTAINED IN THE NEEDLE TUBE. 2. 5 NEEDLES WITH RETENTION SAMPLES WERE SELECTED TO SIMULATE THE TEST VIDEO OF LIQUID INJECTION, AS SHOWN IN THE VIDEO IN ATTACHMENT 4, AND THE TEST RESULTS WERE ALL SMOOTH. 3. 5 NEEDLES WERE SELECTED TO TEST THE RIGIDITY OF NEEDLE TUBES, AND THE TEST RESULTS WERE ALL QUALIFIED, AS SHOWN IN THE APPENDIX (TESTING INSTRUMENT: MEDICAL INJECTION NEEDLE (NEEDLE) RIGIDITY TESTER).

Description of Event or Problem

NEEDLE SHAFT TOO RIGID, NOT ALLOWING ADEQUATE TISSUE GUIDANCE. RED MARKER A/N OF THE ¡§HUB¡§ OF THE NEEDLE CREATES A FALSE POSITIVE FOR THE DETECTION OF A VASCULAR PUNCTURE.