SEPTOJECT

Additional Manufacturer Narrative

REPROCESSED: UNK.

Description of Event or Problem

UF/IMPORTER REPORT #: US-SEPTODONT-(B)(4). #1: EXPOSURE TO CONTAMINATED DEVICE V28.1 (THIS WAS A RE-CAPING INCIDENT) - SERIOUS - UNKNOWN. #2: ACCIDENTAL NEEDLE STICK V28.1 (THE NEEDLE GOT THE DOCTOR¿S FINGER) - SERIOUS - UNKNOWN. #3: ACCIDENTAL OCCUPATIONAL EXPOSURE TO PRODUCT V28.1 (THE NEEDLE GOT THE DOCTOR¿S FINGER) - SERIOUS - UNKNOWN. #4: DEVICE MATERIAL PUNCTURED V28.1 (THE NEEDLE WENT THROUGH THE PLASTIC CAP ) - NOT SERIOUS - UNKNOWN. SPONTANEOUS REPORT FROM THE UNITED STATES. LOCAL REFERENCE: US-SEPTODONT-(B)(4). QUALITY COMPLAINT WAS OPENED: REFERENCES # (B)(4). THIS INITIAL SERIOUS CASE REPORT WAS RECEIVED ON 20-FEB-2026 FROM THE DENTIST VIA SALES REP BY EMAIL. THE REPORT DESCRIBED AN EXPOSURE TO CONTAMINATED DEVICE, INJURY ASSOCIATED WITH DEVICE, ACCIDENTAL EXPOSURE TO PRODUCT, AND DEVICE MATERIAL ISSUE WITH THE SUSPECTED MEDICAL DEVICE SEPTOJECT PRIOR TO AN UNKNOWN PROCEDURE. THIS CASE OCCURRED ON A FEMALE DENTIST OF UNKNOWN AGE. ON AN UNKNOWN DATE, IT WAS REPORTED THAT THE NEEDLE WENT THROUGH THE PLASTIC CAP WHEN USING THE SEPTOJECT NEEDLES EXTRA SHORT (01N1300). IN ONE INSTANCE, THE NEEDLE GOT THE DOCTOR¿S FINGER. SHE PULLED OUT THE NEEDLE AND SHOWED THE SALES REP WITH FORCE HOW IT WENT THROUGH THE PLASTIC. THIS WAS ASSUMED TO BE A RECAPPING INCIDENT. OTHER INFORMATION OF PRODUCT: SEPTOJECT NEEDLES EXTRA SHORT, BATCH NUMBER: #F14107AA, EXPIRY DATE: UNKNOWN. OUTCOME: AT THE TIME OF THE REPORT, THE PATIENT'S OUTCOME WAS UNKNOWN. NO OTHER INFORMATION AVAILABLE. THIS CASE IS SERIOUS AS REPORTED CLINICAL INFORMATION RETRIEVED SERIOUSNESS CRITERIA: OTHER MEDICALLY IMPORTANT CONDITION. MANUFACTURER'S PRELIMINARY COMMENTS: THE REPORT DESCRIBED AN EXPOSURE TO CONTAMINATED DEVICE FOLLOWING NEEDLE INJURY WITH THE SUSPECTED MEDICAL DEVICE SEPTOJECT PRIOR TO AN UNKNOWN PROCEDURE. THE NEEDLE WENT THROUGH THE PLASTIC CAP AND GOT THE DOCTOR¿S FINGER. THIS WAS ASSUMED TO BE A RECAPPING INCIDENT. THEREFORE, PENDING QUALITY INVESTIGATIONS RESULTS AND/OR ADDITIONAL INFORMATION, A USE ERROR OR ABNORMAL USE MAY BE CONSIDERED AND IS PRIVILEGED. BASED ON THE PRELIMINARY ANALYSIS, PENDING QUALITY INVESTIGATION AND IN THE ABSENCE OF ANTERIORITY ON THE BATCH, NO CAPA IS REQUIRED.

Additional Manufacturer Narrative

REPROCESSED: UNK.

Description of Event or Problem

UF/IMPORTER REPORT #: (B)(4). #1: EXPOSURE TO CONTAMINATED DEVICE V28.1 (THIS WAS A RE-CAPING INCIDENT) - SERIOUS - UNKNOWN #2: ACCIDENTAL NEEDLE STICK V28.1 (THE NEEDLE GOT THE DOCTOR¿S FINGER) - SERIOUS - UNKNOWN #3: ACCIDENTAL OCCUPATIONAL EXPOSURE TO PRODUCT V28.1 (THE NEEDLE GOT THE DOCTOR¿S FINGER) - SERIOUS - UNKNOWN. #4: DEVICE MATERIAL PUNCTURED V28.1 (THE NEEDLE WENT THROUGH THE PLASTIC CAP ) - NOT SERIOUS - UNKNOWN. SPONTANEOUS REPORT FROM THE UNITED STATES. LOCAL REFERENCE: (B)(4). QUALITY COMPLAINT WAS OPENED: REFERENCES (B)(4). THIS INITIAL SERIOUS CASE REPORT WAS RECEIVED ON 20-FEB-2026 FROM THE DENTIST VIA SALES REP BY EMAIL. FOLLOW-UP #1 WAS RECEIVED ON 10-APR-2026 FROM THE QUALITY DEPARTMENT. ALL THE INFORMATION WAS PROCESSED TOGETHER. THE REPORT DESCRIBED AN EXPOSURE TO CONTAMINATED DEVICE, INJURY ASSOCIATED WITH DEVICE, ACCIDENTAL EXPOSURE TO PRODUCT, AND DEVICE MATERIAL ISSUE WITH THE SUSPECTED MEDICAL DEVICE SEPTOJECT AFTER AN UNKNOWN PROCEDURE. THIS CASE OCCURRED ON A FEMALE DENTIST OF UNKNOWN AGE. ON AN UNKNOWN DATE, IT WAS REPORTED THAT THE NEEDLE WENT THROUGH THE PLASTIC CAP WHEN USING THE SEPTOJECT NEEDLES EXTRA SHORT (B)(6). IN ONE INSTANCE, THE NEEDLE GOT THE DOCTOR¿S FINGER. SHE PULLED OUT THE NEEDLE AND SHOWED THE SALES REP WITH FORCE HOW IT WENT THROUGH THE PLASTIC. THIS WAS ASSUMED TO BE A RECAPPING INCIDENT. OTHER INFORMATION OF PRODUCT: SEPTOJECT NEEDLES EXTRA SHORT, BATCH NUMBER: #F14107AA, EXPIRY DATE: UNKNOWN. OUTCOME: AT THE TIME OF THE REPORT, THE PATIENT'S OUTCOME WAS UNKNOWN. NO OTHER INFORMATION AVAILABLE. THIS CASE IS SERIOUS AS REPORTED CLINICAL INFORMATION RETRIEVED SERIOUSNESS CRITERIA : OTHER MEDICALLY IMPORTANT CONDITION. CORRECTION PERFORMED TO NARRATIVE ON 09-MAR-2026: NARRATIVE WAS UPDATED FROM "PRIOR TO AN UNKNOWN PROCEDURE" TO "AFTER AN UNKNOWN PROCEDURE" TO DEMONSTRATE REACTION OCCURRED AFTER THE PROCEDURE. FUP #1: RECEIVED QIR. MANUFACTURER'S PRELIMINARY COMMENTS: THE REPORT DESCRIBED AN EXPOSURE TO CONTAMINATED DEVICE FOLLOWING NEEDLE INJURY WITH THE SUSPECTED MEDICAL DEVICE SEPTOJECT AFTER AN UNKNOWN PROCEDURE. THE NEEDLE WENT THROUGH THE PLASTIC CAP AND GOT THE DOCTOR¿S FINGER. THIS WAS ASSUMED TO BE A RECAPPING INCIDENT. THEREFORE, PENDING QUALITY INVESTIGATIONS RESULTS AND/OR ADDITIONAL INFORMATION, A USE ERROR OR ABNORMAL USE MAY BE CONSIDERED AND IS PRIVILEGED. BASED ON THE PRELIMINARY ANALYSIS, PENDING QUALITY INVESTIGATION AND IN THE ABSENCE OF ANTERIORITY ON THE BATCH, NO CAPA IS REQUIRED. MANUFACTURER'S FINAL COMMENTS: THE REPORT DESCRIBED AN EXPOSURE TO CONTAMINATED DEVICE FOLLOWING NEEDLE INJURY WITH THE SUSPECTED MEDICAL DEVICE SEPTOJECT AFTER AN UNKNOWN PROCEDURE. THE NEEDLE WENT THROUGH THE PLASTIC CAP AND GOT THE DOCTOR¿S FINGER. INVESTIGATION ACCORDING TO THE 5-FACTOR METHOD (MATERIALS, METHODS, MANPOWER, MACHINES, ENVIRONMENT) AND THE REVIEW OF THE BATCH RECORDS AND TRACEABILITY DO NOT SHOW ANY DEVIATION OR EVENT THAT COULD BE RELATED OR HAVE IMPACT ON THE REPORTED ISSUE. TO AVOID ANY PRICK¿S RISK DURING USE, WE RECOMMEND FOLLOWING THE IFU DURING DEVICE USE. ALL SPECIFIC WARNINGS INCLUDING RECAPPING WARNING, INSTRUCTIONS OF USE AND CAUTIONS ARE LISTED IN THE IFU AND DELIVERED WITH THE PRODUCT TO PREVENT ANY INCIDENT. THEREFORE, A USE ERROR OR ABNORMAL USE IS PRIVILEDGE AS ROOT CAUSE. THIS DEFECT IS EVALUATED WITH LOW OCCURRENCE GIVEN THE TOTAL QUANTITY SOLD FOR THIS BATCH (NO OTHER COMPLAINT REPORTED TO SOFIC FOR THIS TYPE OF ISSUE OUT OF THE (B)(4) SOLD) AND IS CONSIDERED AS ISOLATED. FOLLOWING THE PERFORMED INVESTIGATION, NO SPECIFIC ROOT CAUSE HAS BEEN IDENTIFIED. HOWEVER, WHILE THE PRACTITIONER CAUSE IS NOT CONFIRMED IT MAY BE SUSPECTED CONSIDERING POSSIBLE RECAPPING BY HAND. SINCE THE ROOT CAUSE IS CONSIDERED TRACED TO USER AND INFORMATION AVAILABLE IN THE IFU, NO SPECIFIC CORRECTIVE ACTION WILL BE IMPLEMENTED. NO SPECIFIC ROOT CAUSE HAS BEEN IDENTIFIED BUT THE PRACTITIONER CAUSE MAY BE SUSPECTED WITH POSSIBLE RECAPPING BY HAND. A USE ERROR OR ABNORMAL USE CANNOT BE EXCLUDED. NO SPECIFIC CORRECTIVE ACTION WILL BE IMPLEMENTED.