SEPTOJECT XL
Report
- Report Number
- 9610964-2021-00015
- Event Type
- Injury
- Date Received
- July 5, 2021
- Date of Event
- June 14, 2021
- Report Date
- October 26, 2021
- Product Code
- DZM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- DENTIST
Narratives
CAUSE INVESTIGATION AND CONCLUSION: BASED ON ALL AVAILABLE DATA, AND QUALITY INVESTIGATIONS RESULTS NO QUALITY DEFECT OF THE DEVICE WAS DETECTED. IN THIS CASE, A SUDDEN MOVEMENT OF PATIENT'S TONGUE TOWARDS THE NEEDLE COULD HAVE BEEN A CAUSATIVE FACTOR OF THE REPORTED INCIDENT. IN ADDITION, THE USE OF A SHORT NEEDLE (30G25MM) SEEMS TO BE INAPPROPRIATE FOR THE TYPE OF PROCEDURE (NERVE BLOCK INJECTION) AND MAY HAVE PLAYED A ROLE. THEREFORE, AS A QUALITY DEFECT OF THE DEVICE COULD BE RULED OUT, WITH REGARDS TO THE DESCRIPTION OF THE INCIDENT, A CAUSE DUE TO DENTIST'S PRACTICE MAY BE SUGGESTED. THIS IS THE FIRST COMPLAINT FOR A "CANNULA BREAKAGE" DEFECT FOR THIS DEVICE BATCH (381'500 DEVICE F05353AA SOLD ; EXPIRATION DATE 2021-06) AND/OR CANNULA BATCH (K1509-005: 3'100'000 CANNULAS). THE CONTROLS DONE BY OUR SUPPLIER AND DURING ASSEMBLY STEP PREVENT THE RISK THE ASSEMBLED DEVICE WITH NON-CONFORM CANNULAS. FURTHERMORE, DURING THE TESTS PERFORMED DUE TO THIS COMPLAINT, NO DEFECT WAS OBSERVED ON THE DEVICE TESTED: NO BREAKAGE DURING BENDING AND RESISTANCE OVER 22N. AFTER INVESTIGATION, AND WITHOUT ANY PROVEN QUALITY DEFECT OF THE NEEDLES, A CAUSE DUE TO DENTIST PRACTICE CANNOT BE RULED OUT. CONSEQUENTLY, WITHOUT ANY OCCURRENCE ON THESE BATCHES OF NEEDLES AND CANNULAS, WITHOUT QUALITY ISSUE IDENTIFIED DURING THIS INVESTIGATION, THE RESIDUAL RISK IS JUDGED ACCEPTABLE. WITHOUT PROVEN CAUSE AND PROVEN QUALITY DEFECT, NO CORRECTIVE ACTION WILL BE DONE FOLLOWING THIS COMPLAINT. MANUFACTURER FINAL COMMENTS: NO DEVIATION OR MAINTENANCE INTERVENTION WITH POSSIBLE IMPACT ON THE QUALITY/RESISTANCE OF CANNULAS HAPPENED DURING THE PRODUCTION OF THESE NEEDLE BATCH (F05353AA). PRACTITIONER RETURNED 4 OPENED NEEDLES INCLUDING 2 NEEDLES WITH BROKEN CANNULA AND PARTIALLY ANSWERED TO THE MANUFACTURER'S QUESTIONNAIRE. CONSEQUENTLY, TESTS WERE PERFORMED DURING THIS INVESTIGATION WAS DONE ON NEEDLES RETURNED AND NEEDLES FROM MANUFACTURER'S RETENTION BOX. NO DEFICIENCY WAS OBSERVED DURING THE TESTS PERFORMED DUE TO THIS COMPLAINT (CANNULA BREAKAGE). AFTER INVESTIGATION, WITHOUT ANY PROVEN QUALITY DEFECT OF THE NEEDLES AND REGARDING THE DESCRIPTION OF THE INCIDENT, A CAUSE DUE TO DENTIST PRACTICE (USE OF A NEEDLE SIZE NON-RECOMMENDED FOR NERVE BLOCK INJECTION) AND CONDITION OF INJECTION (CONSTRAINT ON THE CANNULA BY PATIENT TONGUE) IS PROVEN.
PRELIMINARY RESULTS AND CONCLUSION OF MANUFACTURER'S INVESTIGATION: BASED ON THE FIRST INFORMATION AVAILABLE, ONE OF THE POSSIBLE ROOT CAUSE FOR THE CANNULA BREAKAGE DURING PROCEDURE COULD HAVE BEEN SUDDEN MOVEMENT OF THE PATIENT. GIVEN THAT THE DENTIST REPORTED THAT HE DID NOT BEND THE NEEDLE PRIOR TO INJECTION, AND DID NOT INSERT IT UP TO THE HUB, ONE CASUATIVE FACTOR COULD HAVE BEEN THE PATIENT PUSHING TOWARDS THE SYRINGE WITH HIS TONGUE AND MOVING SUDDENLY. HOWEVER, A QUALITY DEFECT OF THE DEVICE COULD NOT BE RULED OUT; THEREFORE, PENDING QUALITY INVESTIGATIONS RESULTS, NO ROOT CAUSE COULD BE DETERMINED. BASED ON THE PRELIMINARY ANALYSIS, PENDING QUALITY INVESTIGATION AND IN THE ABSENCE OF ANTERIORITY ON THE BATCH, NO CAPA IS REQUIRED. THE CASE WAS SUBMITTED TO FDA ON 05-JUL-2021, HOWEVER WE RECEIVED AN EMAIL FROM FDA ON 30-SEP-2021, THAT SUMMARY REPORT BOX WAS CHECKED AND NUMBER OF EVENTS (NOE) WAS IDENTIFIED AS >1 WHICH AS PER FDA IS INTENDED TO CAPTURE REPORTS SUBMITTED IN SUMMARY FORMAT (VOLUNTARY MALFUNCTION SUMMARY REPORTING (VMSR) PROGRAM). THE EMAIL MENTIONED TO RE-SUBMIT THE CASE WITH CORRECTIONS.
SPONTANEOUS REPORT, FROM FRANCE. LOCAL REFERENCE: #(B)(4). QUALITY COMPLAINT WAS OPENED: REFERENCES #(B)(4). INITIAL SERIOUS CASE REPORT RECEIVED ON 16-JUN-2021 AND FOLLOW-UP #1 INFORMATION RECEIVED ON 18-JUN-2021 DIRECTLY FROM THE DENTIST BY EMAIL. FOLLOW-UP 2 WAS RECEIVED ON 12-OCT-2021 BY EMAIL FROM QUALITY DEPARTMENT. DESCRIPTION OF THE INCIDENT (NARRATIVE): THE REPORT DESCRIBED A CANNULA BREAKAGE AT THE HUB OF THE SUSPECTED DEVICE NEEDLE SEPTOJECT XL DURING A DENTAL ALVEOLAR NERVE BLOCK ANAESTHESIA (AT SPIX THORN) FOR A TOOTH EXTRACTION #47 IN A 60-YEARS OLD MALE PATIENT, LEADING TO DENTAL NEEDLE EXTRACTION BY A STOMATOLOGIST. THE CANNULA WAS NOT ENTIRELY INSERTED UP TO THE HUB AND WAS NOT BENT PRIOR TO INJECTION. ON (B)(6) 2021, DURING THE PROCEDURE, THE PATIENT PUSHED TOWARDS THE SYRINGE WITH HIS TONGUE WITH A SUDDEN MOVEMENT OF PATIENT. THE DENTIST HELD THE PATIENT'S TONGUE AND NOTED THE INCIDENT AFTER THE ANESTHESIA. THE PATIENT WAS REFERRED TO STOMATOLOGIST ON (B)(6) 2021 FOR REMOVAL OF THE CANNULA. NO CONSEQUENCE WAS NOTED AFTER REMOVAL. IT HAS BEEN SPECIFIED THAT THE INCIDENT OCCURED DURING A TOOTH EXTRACTION AFTER 1 INJECTION OF SCANDONEST (MEPIVACAINE HYDROCHLORIDE). THE PATIENT WAS NOT ANXIOUS BEFORE DENTAL TREATMENT. OTHER INFORMATION ON DEVICE: BATCH NUMBER #F05353AA, EXPIRY DATE: JUNE-2021. BASED ON AVAILABLE DATA FROM QUALITY DEPARTMENT: THE PRACTITIONER RETURNED 4 OPENED NEEDLES INCLUDING 2 NEEDLES WITH BROKEN CANNULA AND PARTIALLY ANSWERED TO THE QUESTIONNAIRE. TESTS WERE PERFORMED ON NEEDLES RETURNED AND NEEDLES FROM QUALITY DEPARTMENT RETENTION BOX. NO DEFICIENCY WAS OBSERVED DURING THE TESTS PERFORMED DUE TO THIS COMPLAINT. WITHOUT ANY PROVEN QUALITY DEFECT OF THE NEEDLES AND REGARDING THE DESCRIPTION OF THE INCIDENT, A CAUSE DUE TO DENTIST PRACTICE (USE OF A NEEDLE SIZE NON-RECOMMENDED FOR NERVE BLOCK INJECTION) AND CONDITION OF INJECTION (CONSTRAINT ON THE CANNULA BY PATIENT TONGUE) IS PROVEN. CAUSE INVESTIGATION AND CONCLUSION: BASED ON ALL AVAILABLE DATA, AND QUALITY INVESTIGATIONS RESULTS NO QUALITY DEFECT OF THE DEVICE WAS DETECTED. IN THIS CASE, A SUDDEN MOVEMENT OF PATIENT'S TONGUE TOWARDS THE NEEDLE COULD HAVE BEEN A CAUSATIVE FACTOR OF THE REPORTED INCIDENT. IN ADDITION, THE USE OF A SHORT NEEDLE (30G25MM) SEEMS TO BE INAPPROPRIATE FOR THE TYPE OF PROCEDURE (NERVE BLOCK INJECTION) AND MAY HAVE PLAYED A ROLE. THEREFORE, AS A QUALITY DEFECT OF THE DEVICE COULD BE RULED OUT, WITH REGARDS TO THE DESCRIPTION OF THE INCIDENT, A CAUSE DUE TO DENTIST'S PRACTICE MAY BE SUGGESTED. THIS IS THE FIRST COMPLAINT FOR A "CANNULA BREAKAGE" DEFECT FOR THIS DEVICE BATCH (381'500 DEVICE F05353AA SOLD ; EXPIRATION DATE 2021-06) AND/OR CANNULA BATCH (K1509-005: 3'100'000 CANNULAS). THE CONTROLS DONE BY OUR SUPPLIER AND DURING ASSEMBLY STEP PREVENT THE RISK THE ASSEMBLED DEVICE WITH NON-CONFORM CANNULAS. FURTHERMORE, DURING THE TESTS PERFORMED DUE TO THIS COMPLAINT, NO DEFECT WAS OBSERVED ON THE DEVICE TESTED: NO BREAKAGE DURING BENDING AND RESISTANCE OVER 22N. AFTER INVESTIGATION, AND WITHOUT ANY PROVEN QUALITY DEFECT OF THE NEEDLES, A CAUSE DUE TO DENTIST PRACTICE CANNOT BE RULED OUT. CONSEQUENTLY, WITHOUT ANY OCCURRENCE ON THESE BATCHES OF NEEDLES AND CANNULAS, WITHOUT QUALITY ISSUE IDENTIFIED DURING THIS INVESTIGATION, THE RESIDUAL RISK IS JUDGED ACCEPTABLE. WITHOUT PROVEN CAUSE AND PROVEN QUALITY DEFECT, NO CORRECTIVE ACTION WILL BE DONE FOLLOWING THIS COMPLAINT. MANUFACTURER FINAL COMMENTS: NO DEVIATION OR MAINTENANCE INTERVENTION WITH POSSIBLE IMPACT ON THE QUALITY/RESISTANCE OF CANNULAS HAPPENED DURING THE PRODUCTION OF THESE NEEDLE BATCH (F05353AA). PRACTITIONER RETURNED 4 OPENED NEEDLES INCLUDING 2 NEEDLES WITH BROKEN CANNULA AND PARTIALLY ANSWERED TO THE MANUFACTURER'S QUESTIONNAIRE. CONSEQUENTLY, TESTS WERE PERFORMED DURING THIS INVESTIGATION WAS DONE ON NEEDLES RETURNED AND NEEDLES FROM MANUFACTURER'S RETENTION BOX. NO DEFICIENCY WAS OBSERVED DURING THE TESTS PERFORMED DUE TO THIS COMPLAINT (CANNULA BREAKAGE). AFTER INVESTIGATION, WITHOUT ANY PROVEN QUALITY DEFECT OF THE NEEDLES AND REGARDING THE DESCRIPTION OF THE INCIDENT, A CAUSE DUE TO DENTIST PRACTICE (USE OF A NEEDLE SIZE NON-RECOMMENDED FOR NERVE BLOCK INJECTION) AND CONDITION OF INJECTION (CONSTRAINT ON THE CANNULA BY PATIENT TONGUE) IS PROVEN.
SPONTANEOUS REPORT, FROM FRANCE. LOCAL REFERENCE:#(B)(4). QUALITY COMPLAINT WAS OPENED: REFERENCES #(B)(4). INITIAL SERIOUS CASE REPORT RECEIVED ON (B)(6) 2021 AND FOLLOW-UP #1 INFORMATION RECEIVED ON 18-JUN-2021 DIRECTLY FROM THE DENTIST BY EMAIL. BOTH REPORTS ARE INTEGRATED INTO THE NARRATIVE BELOW. THE REPORT DESCRIBED A CANULA BREAKAGE AT THE HUB OF THE SUSPECTED DEVICE NEEDLE SEPTOJECT XL DURING A DENTAL ALVEOLAR NERVE BLOCK ANAESTHESIA (AT SPIX THORN) FOR A TOOTH EXTRACTION #47 IN A 60-YEARS OLD MALE PATIENT, LEADING TO DENTAL NEEDLE EXTRACTION BY A STOMATOLOGIST. THE CANNULA WAS NOT ENTIRELY INSERTED UP TO THE HUB AND WAS NOT BENT PRIOR TO INJECTION. ON (B)(6) 2021, DURING THE PROCEDURE, THE PATIENT PUSHED TOWARDS THE SYRINGE WITH HIS TONGUE WITH A SUDDEN MOVEMENT OF PATIENT. THE DENTIST HELD THE PATIENT'S TONGUE AND NOTED THE INCIDENT AFTER THE ANESTHESIA. THE PATIENT WAS REFERRED TO STOMATOLOGIST ON (B)(6) 2021 FOR REMOVAL OF THE CANNULA FRAGMENT. NO CONSEQUENCE WAS NOTED AFTER REMOVAL. IT HAS BEEN SPECIFIED THAT THE INCIDENT OCCURED DURING A TOOTH EXTRACTION AFTER 1 INJECTION OF SCANDONEST (MEPIVACAINE HYDROCHLORIDE). THE PATIENT WAS NOT ANXIOUS BEFORE DENTAL TREATMENT. OTHER INFORMATION ON DEVICE: BATCH NUMBER #F05353AA, EXPIRY DATE: JUNE-2021. THE DENTIST CONSIDERED THIS INCIDENT AS NON-SERIOUS. FU#1: ADDITIONAL INFO RECEIVED WITH INCIDENT FORM SENDER COMMENT: CAUSALITY ASSESSMENT ON (B)(6) 2021, ON INITIAL INFORMATION RECEIVED ON (B)(6) 2021 AND FOLLOW-UP INFORMATION #1 RECEIVED ON (B)(6) 2021: A. SERIOUSNESS: SERIOUS (REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE). B. LISTEDNESS/EXPECTEDNESS: EMBEDDED DEVICE: UNEXPECTED FR. NEEDLE ISSUE: UNEXPECTED FR. C. CAUSALITY: A) LATENCY - COMPATIBLE. B) RECOGNIZED ASSOCIATION - NO. C) ANALYSIS - BASED ON THE FIRST INFORMATION AVAILABLE, ONE OF THE POSSIBLE ROOT CAUSE FOR THE CANNULA BREAKAGE DURING PROCEDURE COULD HAVE BEEN SUDDEN MOVEMENT OF THE PATIENT. GIVEN THAT THE DENTIST REPORTED THAT HE DID NOT BEND THE NEEDLE PRIOR TO INJECTION, AND DID NOT INSERT IT UP TO THE HUB, ONE CAUSATIVE FACTOR COULD HAVE BEEN THE PATIENT PUSHING TOWARDS THE SYRINGE WITH HIS TONGUE AND MOVING SUDDENLY. HOWEVER, A QUALITY DEFECT OF THE DEVICE COULD NOT BE RULED OUT; THEREFORE, PENDING QUALITY INVESTIGATIONS RESULTS, NO ROOT CAUSE COULD BE DETERMINED. THE CAUSAL RELATIONSHIP WAS ASSESSED NOT ASSESSABLE. D) DECHALLENGE -NA. E) RECHALLENGE - NA. CONCLUDED CAUSALITY WHO: NOT ASSESSABLE. THE CASE WAS SUBMITTED TO FDA ON 05-JUL-2021, HOWEVER WE RECEIVED AN EMAIL FROM FDA ON 30-SEP-2021, THAT SUMMARY REPORT BOX WAS CHECKED AND NUMBER OF EVENTS (NOE) WAS IDENTIFIED AS 1 WHICH AS PER FDA IS INTENDED TO CAPTURE REPORTS SUBMITTED IN SUMMARY FORMAT (VOLUNTARY MALFUNCTION SUMMARY REPORTING (VMSR) PROGRAM). THE EMAIL MENTIONED TO RE-SUBMIT THE CASE WITH CORRECTIONS.
PRELIMINARY RESULTS AND CONCLUSION OF MANUFACTURER'S INVESTIGATION: BASED ON THE FIRST INFORMATION AVAILABLE, ONE OF THE POSSIBLE ROOT CAUSE FOR THE CANNULA BREAKAGE DURING PROCEDURE COULD HAVE BEEN SUDDEN MOVEMENT OF THE PATIENT. GIVEN THAT THE DENTIST REPORTED THAT HE DID NOT BEND THE NEEDLE PRIOR TO INJECTION, AND DID NOT INSERT IT UP TO THE HUB, ONE CASUATIVE FACTOR COULD HAVE BEEN THE PATIENT PUSHING TOWARDS THE SYRINGE WITH HIS TONGUE AND MOVING SUDDENLY. HOWEVER, A QUALITY DEFECT OF THE DEVICE COULD NOT BE RULED OUT; THEREFORE, PENDING QUALITY INVESTIGATIONS RESULTS, NO ROOT CAUSE COULD BE DETERMINED. BASED ON THE PRELIMINARY ANALYSIS, PENDING QUALITY INVESTIGATION AND IN THE ABSENCE OF ANTERIORITY ON THE BATCH, NO CAPA IS REQUIRED.
SPONTANEOUS REPORT, FROM (B)(6). LOCAL REFERENCE:#(B)(4). QUALITY COMPLAINT WAS OPENED: REFERENCES #(B)(4). INITIAL SERIOUS CASE REPORT RECEIVED ON 16-JUN-2021 AND FOLLOW-UP #1 INFORMATION RECEIVED ON 18-JUN-2021 DIRECTLY FROM THE DENTIST BY EMAIL. BOTH REPORTS ARE INTEGRATED INTO THE NARRATIVE BELOW. THE REPORT DESCRIBED A CANULA BREAKAGE AT THE HUB OF THE SUSPECTED DEVICE NEEDLE SEPTOJECT XL DURING A DENTAL ALVEOLAR NERVE BLOCK ANAESTHESIA (AT SPIX THORN) FOR A TOOTH EXTRACTION #47 IN A (B)(6) YEARS OLD MALE PATIENT, LEADING TO DENTAL NEEDLE EXTRACTION BY A STOMATOLOGIST. THE CANNULA WAS NOT ENTIRELY INSERTED UP TO THE HUB AND WAS NOT BENT PRIOR TO INJECTION. ON (B)(6) 2021, DURING THE PROCEDURE, THE PATIENT PUSHED TOWARDS THE SYRINGE WITH HIS TONGUE WITH A SUDDEN MOVEMENT OF PATIENT. THE DENTIST HELD THE PATIENT'S TONGUE AND NOTED THE INCIDENT AFTER THE ANESTHESIA. THE PATIENT WAS REFERRED TO STOMATOLOGIST ON (B)(6) 2021 FOR REMOVAL OF THE CANNULA FRAGMENT. NO CONSEQUENCE WAS NOTED AFTER REMOVAL. IT HAS BEEN SPECIFIED THAT THE INCIDENT OCCURED DURING A TOOTH EXTRACTION AFTER 1 INJECTION OF SCANDONEST (MEPIVACAINE HYDROCHLORIDE). THE PATIENT WAS NOT ANXIOUS BEFORE DENTAL TREATMENT. OTHER INFORMATION ON DEVICE: BATCH NUMBER #F05353AA, EXPIRY DATE: JUNE-2021. THE DENTIST CONSIDERED THIS INCIDENT AS NON-SERIOUS. FU#1: ADDITIONAL INFO RECEIVED WITH INCIDENT FORM. SENDER COMMENT: CAUSALITY ASSESSMENT ON 21-JUN-201, ON INITIAL INFORMATION RECEIVED ON 16-JUN-2021 AND FOLLOW-UP INFORMATION #1 RECEIVED ON 18-JUN-2021: SERIOUSNESS: SERIOUS (REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE). LISTEDNESS/EXPECTEDNESS: EMBEDDED DEVICE: UNEXPECTED FR NEEDLE ISSUE: UNEXPECTED FR. CAUSALITY. LATENCY - COMPATIBLE. RECOGNIZED ASSOCIATION - NO. BASED ON THE FIRST INFORMATION AVAILABLE, ONE OF THE POSSIBLE ROOT CAUSE FOR THE CANNULA BREAKAGE DURING PROCEDURE COULD HAVE BEEN SUDDEN MOVEMENT OF THE PATIENT. GIVEN THAT THE DENTIST REPORTED THAT HE DID NOT BEND THE NEEDLE PRIOR TO INJECTION, AND DID NOT INSERT IT UP TO THE HUB, ONE CASUATIVE FACTOR COULD HAVE BEEN THE PATIENT PUSHING TOWARDS THE SYRINGE WITH HIS TONGUE AND MOVING SUDDENLY. HOWEVER, A QUALITY DEFECT OF THE DEVICE COULD NOT BE RULED OUT; THEREFORE, PENDING QUALITY INVESTIGATIONS RESULTS, NO ROOT CAUSE COULD BE DETERMINED. THE CAUSAL RELATIONSHIP WAS ASSESSED NOT ASSESSABLE. DECHALLENGE -NA. RECHALLENGE - NA. CONCLUDED CAUSALITY WHO: NOT ASSESSABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1015906 | SEPTOJECT XL | DENTAL SYRINGE NEEDLE, SINGLE-USE | DZM | 30G25 MM | F05353AA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention | SCANDONEST 30 MG/ML.| SCANDONEST 30 MG/ML. |