ULTRA SAFETY PLUS TWIST PART A (INJECTION DEVICE)
Report
- Report Number
- 1000477999-2024-00003
- Event Type
- Injury
- Date Received
- May 21, 2024
- Date of Event
- May 13, 2024
- Report Date
- July 3, 2024
- Manufacturer
- SEPTODONT S.A.S.
- Product Code
- DZM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
FOR FINAL (REPORTABLE INCIDENT): DESCRIPTION OF THE MANUFACTURER'S EVALUATION CONCERNING POSSIBLE ROOT CAUSES/CAUSATIVE FACTORS AND CONCLUSION: THE INCRIMINATED DEFECTIVE SAMPLE WASN'T RETURNED FOR INVESTIGATION, TESTS WERE CARRIED OUT ON SOFIC RETENTION SAMPLES. THE FOLLOWING TESTS WERE CARRIED OUT: FUNCTIONAL CONTROL AND FUNCTIONAL TESTS WITH UNUSUAL CONDITIONS AND STRESS. WHEN TESTING THE DEVICES (CORRECTLY FIXED ON THE HANDLE) IN UNUSUAL CONDITIONS AND STRESS (WE APPLIED A STRONG PRESSURE WITH TWO HANDS), THE DEVICES REMAINED ATTACHED TO THE HANDLE FOR ALL TESTED DEVICES, NO DEVICE WAS DISCONNECTED. ALL TESTED NEEDLES DID COMPLY WITH THE SPECIFICATIONS. NO QUALITY ISSUES WERE DETECTED ON THE PRODUCTS FROM THIS BATCH DURING TESTING. IN THE ABSENCE OF DEFECT DURING INVESTIGATION AND TESTS, THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OTHER FACTORS MAY LEAD TO THE REPORTED ISSUE: - EXCESSIVE PRESSURE DURING INJECTION ASSOCIATED TO A WRONG ASSEMBLY BETWEEN THE HANDLE AND THE INJECTION DEVICE - USE OF A WRONG HANDLE (NOT TWIST HANDLE) - WRONG ASSEMBLY: THE ERGOT THE HANDLE WAS NOT "TWISTED" IN THE L-SHAPE OF THE USP TWIST AND/OR PARTIAL INSERTION OF THE SHEATH IN THE HANDLE - USE OF MULTIPLE CARTRIDGES. ACCORDING THE QIR AND THE INFORMATION REPORTED, USE ERROR/ABNORMAL USE IS MAINLY CONSIDERED. RESULTS OF THE ASSESSMENT: ACCORDING THE INFORMATION REPORTED, USE ERROR RISK IS CONSIDERED IN THE RISK TABLE (ARARRIS012_04). HOWEVER, THE EXACT ROOT CAUSE IS NOT IDENTIFIED BUT SEVERAL HYPOTHESIS ARE CONCLUDED ACCORDING TO THE QIR (SUCH AS THE RISK : USE USPTW2-001). THE HAZARDOUS SITUATION OF HANDLE DISASSEMBLY IS IDENTIFIED WITH A PATIENT HARM OF ACCIDENTAL INGESTION OF THE CANNULA. THIS DEFECT IS EVALUATED WITH LOW OCCURRENCE GIVEN THE TOTAL QUANTITY SOLD FOR THIS BATCH AND IS CONSIDERED AS ISOLATED. DESCRIPTION OF REMEDIAL ACTION/CORRECTIVE ACTION/PREVENTIVE ACTION/FIELD SAFETY CORRECTIVE ACTION (FSCA): FOLLOWING THE PERFORMED INVESTIGATION, THE EXACT ORIGIN OF THE CLAIMED ISSUE REMAINS UNIDENTIFIED, THEREFORE, NO SPECIFIC CORRECTIVE ACTION WILL BE IMPLEMENTED. FINAL COMMENTS FROM THE MANUFACTURER: NO QUALITY DEFECT CONCLUDED. USE ERROR/ABNORMAL USE IS CONSIDERED AS THE ROOT CAUSE (THE EXACT ROOT CAUSE NOT IDENTIFIED BUT HYPOTHESIS ACCORDING TO THE QIR). NO CAPA IMPLEMENTED.
REPROCESSED: UNK.
REPROCESSED: UNK.
SPONTANEOUS REPORT FROM UNITED KINGDOM LOCAL REFERENCE: (B)(4) # CC101137. QUALITY COMPLAINT WAS OPENED: REFERENCES (B)(4). THIS INITIAL SERIOUS CASE REPORT WAS RECEIVED ON 14-MAY-2024 FROM LEAD REGULATORY OFFICER VIA LOCAL AFFILIATE BY EMAIL AND FOLLOW-UP # 1 RECEIVED ON 15-MAY-2024 FROM AU 3 WAS RECEIVED ON 21-JUN-2024 FROM THE QUALITY DEPARTMENT. ALL INFORMATION WERE PROCESSED TOGETHER. INCIDENT DESCRIPTION NARRATIVE: THIS REPORT DESCRIBED DEVICE MATERIAL SEPARATION, NEEDLE BROKEN, ACCIDENTAL DEVICE INGESTION, DEVICE DIFFICULT TO HANDLE AND DEVICE FAIL-SAFE MECHANISM ISSUE OF SUSPECTED DEVICE INJECTION ULTRA SAFETY PLUS TWIST IN A 38 YEAR-OLD FEMALE PATIENT DURING AN UNSPECIFIED PROCEDURE. NO FURTHER INFORMATION WAS AVAILABLE REGARDING THE PATIENT. ON 13-MAY-2024, THE DENTIST WAS ADMINISTERING LOCAL ANAESTHETIC USING AN ULTRA SAFETY PLUS SYRINGE AND NEEDLE FOR THE BUCCAL AND PALATAL INFILTRATIONS. THE LOCKING SYSTEM FAILED ON THE LAST PALATAL INJECTION. A NEW CARTRIDGE HAD BEEN INSERTED. THE EFFECT WAS THAT THE SURGEONS HAND MOVED AT SPEED TOWARDS THE HARD PALATE CAUSING THE CANNULA TO BEND SEVERELY IN SEVERAL PLACES. THE BARREL FAILED AND SNAPPED THE NEEDLE WHILST IT WAS IN USE. THE DENTIST SAT THE PATIENT UP AND TOLD THE PATIENT NOT TO SWALLOW. THE DENTIST ATTEMPTED TO REMOVE THE BROKEN PIECE OF THE NEEDLE HOWEVER THE PATIENT SWALLOWED AND THE DENTIST WAS UNABLE TO LOCATE THE NEEDLE FRAGMENT. TREATMENT WAS THEN ABORTED AND ADVISED THE PATIENT TO ATTEND PATIENT TO THE HOSPITAL FOR AN X-RAY. THE DENTIST PHONED THE PATIENT TO FOLLOW UP HOW SHE WAS AND SHE ADVISED COUGHED THE FRAGMENT UP WHILST WAITING AT THE HOSPITAL TO BE SEEN. SHE BROUGHT THE FRACTURED FRAGMENT BACK INTO THE PRACTICE. OTHER INFORMATION OF PRODUCT: SEPTODONT ULTRA SAFETY PLUS TWIST (PART A AND PART B (BLUE HANDLE) 30G/0,30MM 25 MM SHORT 2.2 ML, BATCH: F52096AA, EXPIRY DATE: 31-JUL-2028 CONCOMITANT MEDICATIONS INCLUDED: SEPTANEST (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE), 2 CARTRIDGES (BATCH: B32479AA, EXPIRY DATE: 02-MAY-2025. THIS CASE IS CONSIDERED AS SERIOUS AS IT RETRIEVED THE FOLLOWING SERIOUS CRITERIA: OTHER IMPORTANT MEDICAL EVENT. -------------------------------------------- FOLLOW-UP #2: ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT DATE OF BIRTH, ADDITIONAL EVENT (DEVICE FAIL-SAFE MECHANISM ISSUE), ADDITIONAL IMDRF CODING FAIL-SAFE PROBLEM AND DESCRIPTION OF THE INCIDENT. FOLLOW-UP #3: RECEIVED QIR. MANUFACTURER'S PRELIMINARY COMMENTS: THIS REPORT DESCRIBED DEVICE MATERIAL SEPARATION, NEEDLE BROKEN, ACCIDENTAL DEVICE INGESTION, DEVICE DIFFICULT TO HANDLE AND DEVICE FAIL-SAFE MECHANISM ISSUE OF SUSPECTED DEVICE INJECTION ULTRA SAFETY PLUS TWIST IN A 38 YEAR-OLD FEMALE PATIENT FOR THE BUCCAL AND PALATAL INFILTRATIONS. THE LOCKING SYSTEM FAILED ON THE LAST PALATAL INJECTION. A NEW CARTRIDGE HAD BEEN INSERTED. THE EFFECT WAS THAT THE SURGEONS HAND MOVED AT SPEED TOWARDS THE HARD PALATE CAUSING THE CANNULA TO BEND SEVERELY IN SEVERAL PLACES. THE BARREL FAILED AND SNAPPED THE NEEDLE WHILST IT WAS IN USE. USE ERROR IS CONSIDERED SINCE NEEDLE BENDING DUE TO SURGEON MISHANDLING MAY BE THE CAUSE OF THE NEEDLE BREAKAGE. IN ADDITION, USP TWIST HAS A UNIQUE LOCK SYSTEM THAT SHOULD REDUCE THE RISK OF DISMANTLING OF THE DEVICE. IF NOT CORRECTLY LOCKED BY A TWIST BEFORE USE AS MENTIONED IN THE INSTRUCTION FOR USE, SO THAT THE TABS COME TO BE LODGED IN THE "L-SHAPE" (GROOVES) OF PART A, THE DIFFERENT PARTS OF THE DEVICE MAY SEPARATE DURING USE. THE ACCIDENTAL DEVICE INGESTION MAY BE A SWALLOWING REFLEX OF THE PATIENT DESPITE THE DENTIST WARNING HIM NOT TO SWALLOW. IT WAS REPORTED THAT THE PATIENT BROUGHT THE FRACTURED FRAGMENT BACK INTO THE PRACTICE. PENDING QUALITY INVESTIGATION RESULTS AND/OR FURTHER INFORMATION, QUALITY DEFECT CANNOT BE EXCLUDED AND EXACT ROOT CAUSE CANNOT BE CONCLUDED YET. BASED ON THE PRELIMINARY ANALYSIS, PENDING QUALITY INVESTIGATION, NO CAPA IS REQUIRED.
MFR REPORT #: GB-SEPTODONT-2024018643 / 1000477999-2024-00003. #1: ACCIDENTAL DEVICE INGESTION V27.0 (DENTIST ATTEMPTED TO REMOVE THE BROKEN PIECE OF THE NEEDLE HOWEVER THE PATIENT SWALLOWED; WAS UNABLE TO LOCATE THE NEEDLE FRAGMENT): FROM (B)(6) 2024 TO - SERIOUS - UNKNOWN. #2: DEVICE MATERIAL SEPARATION V27.0 (THE BARREL FAILED): FROM (B)(6) 2024 TO - NOT SERIOUS - UNKNOWN. #3: NEEDLE BROKEN V27.0 (SNAPPED THE NEEDLE WHILST IT WAS IN USE): FROM (B)(6) 2024 TO - NOT SERIOUS - UNKNOWN. #4: DEVICE DIFFICULT TO HANDLE V27.0 (A LOT OF PRESSURE HAD TO BE EXERTED ON THE DEVICE): FROM (B)(6) 2024 TO - NOT SERIOUS - UNKNOWN. #5: DEVICE FAIL-SAFE MECHANISM ISSUE V27.0 (THE LOCKING SYSTEM FAILED): FROM (B)(6) 2024 TO - NOT SERIOUS - UNKNOWN. SPONTANEOUS REPORT FROM UNITED KINGDOM LOCAL REFERENCE: GB-SEPTODONT-2024018643, #(B)(4). QUALITY COMPLAINT WAS OPENED: REFERENCES (B)(4). THIS INITIAL SERIOUS CASE REPORT WAS RECEIVED ON 14-MAY-2024 FROM LEAD REGULATORY OFFICER VIA LOCAL AFFILIATE BY EMAIL AND FOLLOW-UP #1 RECEIVED ON 15-MAY-2024 FROM AUTHORITY BY EMAIL. FOLLOW-UP #2 WAS RECEIVED ON 20-MAY-2024 FROM THE DENTIST. ALL INFORMATION WERE PROCESSED TOGETHER. THIS REPORT DESCRIBED DEVICE MATERIAL SEPARATION, NEEDLE BROKEN, ACCIDENTAL DEVICE INGESTION, DEVICE DIFFICULT TO HANDLE AND DEVICE FAIL-SAFE MECHANISM ISSUE OF SUSPECTED DEVICE INJECTION ULTRA SAFETY PLUS TWIST IN A 38 YEAR-OLD FEMALE PATIENT DURING AN UNSPECIFIED PROCEDURE. NO FURTHER INFORMATION WAS AVAILABLE REGARDING THE PATIENT. ON (B)(6) 2024, THE DENTIST WAS ADMINISTERING LOCAL ANAESTHETIC USING AN ULTRA SAFETY PLUS SYRINGE AND NEEDLE FOR THE BUCCAL AND PALATAL INFILTRATIONS. THE LOCKING SYSTEM FAILED ON THE LAST PALATAL INJECTION. A NEW CARTRIDGE HAD BEEN INSERTED. THE EFFECT WAS THAT THE SURGEONS HAND MOVED AT SPEED TOWARDS THE HARD PALATE CAUSING THE CANNULA TO BEND SEVERELY IN SEVERAL PLACES. THE BARREL FAILED AND SNAPPED THE NEEDLE WHILST IT WAS IN USE. THE DENTIST SAT THE PATIENT UP AND TOLD THE PATIENT NOT TO SWALLOW. THE DENTIST ATTEMPTED TO REMOVE THE BROKEN PIECE OF THE NEEDLE HOWEVER THE PATIENT SWALLOWED AND THE DENTIST WAS UNABLE TO LOCATE THE NEEDLE FRAGMENT. TREATMENT WAS THEN ABORTED AND ADVISED THE PATIENT TO ATTEND PATIENT TO THE HOSPITAL FOR AN X-RAY. THE DENTIST PHONED THE PATIENT TO FOLLOW UP HOW SHE WAS AND SHE ADVISED COUGHED THE FRAGMENT UP WHILST WAITING AT THE HOSPITAL TO BE SEEN. SHE BROUGHT THE FRACTURED FRAGMENT BACK INTO THE PRACTICE. OTHER INFORMATION OF PRODUCT: SEPTODONT ULTRA SAFETY PLUS TWIST (PART A AND PART B (BLUE HANDLE) 30G/0,30MM 25 MM SHORT 2.2 ML, BATCH: F52096AA, EXPIRY DATE: 31-JUL-2028. CONCOMITANT MEDICATIONS INCLUDED: SEPTANEST (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTARATE), 2 CARTRIDGES (BATCH: B32479AA, EXPIRY DATE: 02-MAY-2025. THIS CASE IS CONSIDERED AS SERIOUS AS IT RETREIVED THE FOLLOWING SERIOUS CRITERIA: OTHER IMPORTANT MEDICAL EVENT. FOLLOW-UP #2: ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT DATE OF BIRTH, ADDITIONAL EVENT (DEVICE FAIL-SAFE MECHANISM ISSUE), ADDITIONAL IMDRF CODING FAEIL-SAFE PROBLEM AND DESCRIPTION OF THE INCIDENT. MANUFACTURER'S PRELIMINARY COMMENTS: BASED ON THE INFORMATION AVAILABLE, THE REPORT DESCRIBED DEVICE MATERIAL SEPARATION, NEEDLE BROKEN AND ACCIDENTAL DEVICE INGESTION OF SUSPECTED DEVICE INJECTION ULTRA SAFETY PLUS TWIST IN A 38 YEAR-OLD FEMALE PATIENT DURING AN UNSPECIFIED PROCEDURE. DEVICE MATERIAL SEPARATION AND NEEDLE BROKEN MAY HAPPEN DUE TO A POSSIBLE PRESSURE EXERCED BY THE PRACTITIONER OR A MISHANDLING OF THE DEVICE. IN ADDITION, USP TWIST HAS A UNIQUE LOCK SYSTEM THAT SHOULD REDUCE THE RISK OF DISMANTLING OF THE DEVICE. IF NOT CORRECTLY LOCKED BY A TWIST BEFORE USE AS MENTIONED IN THE INSTRUCTION FOR USE, SO THAT THE TABS COME TO BE LODGED IN THE "L-SHAPE" (GROOVES) OF PART A, THE DIFFERENT PARTS OF THE DEVICE MAY SEPARATE DURING USE. THE ACCIDENTAL DEVICE INGESTION MAY BE A SWALLOWIG REFLEX OF THE PATIENT DESPITE THE DENTIST WARNING HIM NOT TO SWALLOW. IT WAS REPORTED THAT THE PATIENT BROUGHT THE FRACTURED FRAGMENT BACK INTO THE PRACTICE. PENDING QUALITY INVESTIGATION RESULTS AND/OR FURTHER INFORMATION, QUALITY DEFECT CANNOT BE EXCLUDED AND EXACT ROOT CAUSE CANNOT BE IDENTIFIED. USE ERROR/ABNORMAL USE CANNOT BE EXCLUDED NEITHER. BASED ON THE PRELIMINARY ANALYSIS, PENDING QUALITY INVESTIGATION, NO CAPA IS REQUIRED.
MFR REPORT #: (B)(4). #1: ACCIDENTAL DEVICE INGESTION V27.0 (DENTIST ATTEMPTED TO REMOVE THE BROKEN PIECE OF THE NEEDLE HOWEVER THE PATIENT SWALLOWE ; WAS UNABLE TO LOCATE THE NEEDLE FRAGMENT): FROM 13-MAY-2024 TO - SERIOUS - UNKNOWN. #2: DEVICE MATERIAL SEPARATION V27.0 (THE BARREL FAILED): FROM 13-MAY-2024 TO - NOT SERIOUS - UNKNOWN. #3: NEEDLE BROKEN V27.0 (SNAPPED THE NEEDLE WHILST IT WAS IN USE): FROM 13-MAY-2024 TO - NOT SERIOUS - UNKNOWN. SPONTANEOUS REPORT FROM UNITED KINGDOM. LOCAL REFERENCE: (B)(4), # (B)(4). QUALITY COMPLAINT WAS OPENED: REFERENCES (B)(4). THIS INITIAL SERIOUS CASE REPORT WAS RECEIVED ON 14-MAY-2024 FROM LEAD REGULATORY OFFICER VIA LOCAL AFFILIATE BY EMAIL AND FOLLOW-UP #1 RECEIVED ON 15-MAY-2024 FROM AUTHORITY BY EMAIL WERE PROCESSED TOGETHER. THIS REPORT DESCRIBED DEVICE MATERIAL SEPARATION, NEEDLE BROKEN AND ACCIDENTAL DEVICE INGESTION OF SUSPECTED DEVICE INJECTION ULTRA SAFETY PLUS TWIST IN A 38 YEAR-OLD FEMALE PATIENT DURING AN UNSPECIFIED PROCEDURE. NO FURTHER INFORMATION WAS AVAILABLE REGARDING THE PATIENT. ON (B)(6) 2024, THE DENTIST WAS ADMINISTERING LOCAL ANAESTHETIC USING AN ULTRA SAFETY PLUS SYRINGE AND NEEDLE. THE BARREL FAILED AND SNAPPED THE NEEDLE WHILST IT WAS IN USE. THE DENTIST SAT THE PATIENT UP AND TOLD THE PATIENT NOT TO SWALLOW. THE DENTIST ATTEMPTED TO REMOVE THE BROKEN PIECE OF THE NEEDLE HOWEVER THE PATIENT SWALLOWED AND THE DENTIST WAS UNABLE TO LOCATE THE NEEDLE FRAGMENT. TREATMENT WAS THEN ABORTED AND ADVISED THE PATIENT TO ATTEND PATIENT TO THE HOSPITAL FOR AN XRAY. THE DENTIST PHONED THE PATIENT TO FOLLOW UP HOW SHE WAS AND SHE ADVISED COUGHED THE FRAGMENT UP WHILST WAITING AT THE HOSPITAL TO BE SEEN. SHE BROUGHT THE FRACTURED FRAGMENT BACK INTO THE PRACTICE. OTHER INFORMATION OF PRODUCT: SEPTODONT ULTRA SAFETY PLUS TWIST ULTRA SAFETY PLUS TWIST 30G/0,30MM 25 MM SHORT 2.2 ML, BATCH: F52096AA, EXPIRY DATE: 31-JUL-2028. THIS CASE IS CONSIDERED AS SERIOUS AS IT RETRIEVED THE FOLLOWING SERIOUS CRITERIA: OTHER IMPORTANT MEDICAL EVENT. MANUFACTURER'S PRELIMINARY COMMENTS: BASED ON THE INFORMATION AVAILABLE, THE REPORT DESCRIBED DEVICE MATERIAL SEPARATION, NEEDLE BROKEN AND ACCIDENTAL DEVICE INGESTION OF SUSPECTED DEVICE INJECTION ULTRA SAFETY PLUS TWIST IN A 38 YEAR-OLD FEMALE PATIENT DURING AN UNSPECIFIED PROCEDURE. DEVICE MATERIAL SEPARATION AND NEEDLE BROKEN MAY HAPPEN DUE TO A POSSIBLE PRESSURE EXERCED BY THE PRACTITIONER OR A MISHANDLING OF THE DEVICE. IN ADDITION, USP TWIST HAS A UNIQUE LOCK SYSTEM THAT SHOULD REDUCE THE RISK OF DISMANTLING OF THE DEVICE. IF NOT CORRECTLY LOCKED BY A TWIST BEFORE USE AS MENTIONED IN THE INSTRUCTION FOR USE, SO THAT THE TABS COME TO BE LODGED IN THE "L-SHAPE" (GROOVES) OF PART A, THE DIFFERENT PARTS OF THE DEVICE MAY SEPARATE DURING USE. THE ACCIDENTAL DEVICE INGESTION MAY BE A SWALLOWING REFLEX OF THE PATIENT DESPITE THE DENTIST WARNING HIM NOT TO SWALLOW. IT WAS REPORTED THAT THE PATIENT BROUGHT THE FRACTURED FRAGMENT BACK INTO THE PRACTICE. PENDING QUALITY INVESTIGATION RESULTS AND/OR FURTHER INFORMATION, QUALITY DEFECT CANNOT BE EXCLUDED AND EXACT ROOT CAUSE CANNOT BE IDENTIFIED. USE ERROR/ABNORMAL USE CANNOT BE EXCLUDED NEITHER. BASED ON THE PRELIMINARY ANALYSIS, PENDING QUALITY INVESTIGATION, NO CAPA IS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1616928 | ULTRA SAFETY PLUS TWIST PART A (INJECTION DEVICE) | DENTAL SYRINGE NEEDLE, SINGLE-USE | DZM | SEPTODONT S.A.S. | ULTRA SAFETY PLUS TWIST | F52096AA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Female | Other | SEPTANEST 2.2ML| STERILISATION POUCH| STERILISATION POUCH |