LOCAL DATA (GDPR)

Additional Manufacturer Narrative

REPROCESSED: UNK.

Description of Event or Problem

MFR REPORT #: (B)(4). #1: EXPOSURE TO DEVICE CONTAMINATED WITH BODY FLUID V29.0 (INCIDENTS OF BLOOD EXPOSURE): FROM (B)(6) 2026 - SERIOUS - UNKNOWN. #2: OCCUPATIONAL EXPOSURE TO PRODUCT V29.0 (OCCUPATIONAL EXPOSURE): FROM (B)(6) 2026 - SERIOUS - UNKNOWN. #3: DEVICE FAIL-SAFE MECHANISM ISSUE V29.0 (SAFETY ISSUE WITH THE NEEDLES): FROM (B)(6) 2026 - SERIOUS - UNKNOWN. #4: ACCIDENTAL NEEDLE STICK V29.0 (ACCIDENTAL NEEDLE STICK): FROM (B)(6) 2026 - SERIOUS - UNKNOWN. SPONTANEOUS REPORT FROM EUROPE. LOCAL REFERENCE: (B)(4). QUALITY COMPLAINT WAS OPENED: REFERENCES # (B)(4). THIS INITIAL SERIOUS CASE REPORT WAS RECEIVED ON 03-JUN-2026 FROM HOSPITAL (APHP) VIA SEPTODONT WEBSITE AND FOLLOW-UP#1 RECEIVED ON 04-JUN-2026 FROM THE HEALTH AUTHORITY BY EMAIL WERE PROCESSED TOGETHER. THE REPORT DESCRIBED A MALFUNCTION IN THE NEEDLE SAFETY DEVICE THAT CAUSED TWO INCIDENTS OF BLOOD EXPOSURE WITH THE SUSPECTED MEDICAL DEVICE ULTRA SAFETY PLUS TWIST PART A (INJECTION DEVICE). THIS CASE OCCURRED ON 2 UNSPECIFIED STUDENTS. NO ADDITIONAL INFORMATION WAS AVAILABLE ON PATIENTS. ON (B)(6) 2026, DURING AN ANESTHESIA PROCEDURE, THE NEEDLE SAFETY MECHANISM MALFUNCTIONED, AND 2 STUDENTS PRICKED THE PALM OF THEIR HAND. BLOOD EXPOSURE WAS REPORTED. ON THE SAME DATE, 1 ACCIDENT WAS PREVENTED. OUTCOME: AT THE TIME OF THE REPORT, NO ADVERSE EVENT WAS REPORTED. OTHER INFORMATION OF PRODUCT: ULTRA SAFETY PLUS TWIST PART A (INJECTION DEVICE), BATCH NUMBER : #F52340AA (SEPTODONT BATCH A134524) , EXPIRY DATE : 31-MAY-2030. THIS CASE WAS CONSIDERED AS SERIOUS DUE TO OTHER MEDICALLY IMPORTANT CONDITION. NO OTHER INFORMATION AVAILABLE. FOLLOW-UP #1 RECEIVED ON 04-JUN-2026: ACCIDENTAL NEEDLE STICK CONFIRMED (ADDED TO EVENT). MANUFACTURER'S PRELIMINARY COMMENTS: BASED ON THE INFORMATION AVAILABLE, THE REPORT DESCRIBED TWO INCIDENTS OF BLOOD EXPOSURE WITH THE SUSPECTED MEDICAL DEVICE ULTRA SAFETY PLUS TWIST PART A (INJECTION DEVICE). DURING AN ANESTHESIA PROCEDURE, THE NEEDLE SAFETY MECHANISM MALFUNCTIONED, AND 2 STUDENTS PRICKED THE PALM OF THEIR HAND. BLOOD EXPOSURE WAS REPORTED. AT THE TIME OF THIS REPORT, NO ADVERSE EVENT WAS REPORTED. WITHOUT QUALITY INVESTIGATIONS, QUALITY ISSUE CANNOT BE EXCLUDED, USE ERROR/ABNORMAL USE CANNOT BE EXCLUDED. #FU1 CONSIDERED. NO CAPA IS REQUIRED.