DARBY PLASTIC HUB NEEDLE 30GA SHORT
Report
- Report Number
- 3002987375-2025-00001
- Event Type
- Injury
- Date Received
- July 17, 2025
- Report Date
- July 31, 2025
- Manufacturer
- SOFIC
- Product Code
- DZM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
REPROCESSED: UNK.
REPROCESSED: UNK
REPROCESSED: UNK.
MFR REPORT #: (B)(4) / 3002987375-2025-00001. #1: NEEDLE BROKEN V28.0 (NEEDLES BREAKING AT HUB): FROM TO - SERIOUS. #2: DEVICE FRAGMENT EMBEDDED V28.0 (HAD TO SEND PATIENT TO OMFS FOR REMOVAL AS NEEDLE BROKE IN THEIR MOUTH. OMFS REMOVED THE NEEDLE AND PATIENT GOT A FEW STITCHES): FROM TO - SERIOUS - UNKNOWN. SPONTANEOUS REPORT FROM THE UNITED STATES. LOCAL REFERENCE: (B)(4). QUALITY COMPLAINT WAS OPENED: REFERENCES #(B)(4); (B)(4). THIS INITIAL SERIOUS CASE REPORT WAS RECEIVED ON 10-JUL-2025 FROM DENTIST BY EMAIL VIA DISTRIBUTOR. FOLLOW-UP #1 WAS RECEIVED ON 21-JUL-2025 FROM DENTIST VIA PHONE CALL. ALL THE INFORMATION WERE PROCESSED TOGETHER. THE REPORT DESCRIBED NEEDLE BROKEN AND DEVICE FRAGMENT EMBEDDED WITH THE SUSPECTED MEDICAL DEVICE DARBY PLASTIC HUB NEEDLE 30GA SHORT PRIOR TO ROOT CANAL OF TOOTH NUMBER 30. THIS CASE OCCURRED ON A FEMALE PATIENT WHO WAS APPROXIMATELY 40 YEARS OLD WITH AN UNSPECIFIED MEDICAL HISTORY. NO ADDITIONAL INFORMATION WAS AVAILABLE ON THE PATIENT. ON AN UNSPECIFIED DATE, IT WAS REPORTED THAT THE NEEDLE BROKE AT THE HUB. THE NEEDLE WAS DEEPLY EMBEDDED IN THE PATIENT'S GUM. THE DOCTOR HAD TO SEND THE PATIENT TO ORAL AND MAXILLOFACIAL SURGEON (OMFS) FOR REMOVAL AS NEEDLE BROKE IN THEIR MOUTH. OMFS REMOVED THE NEEDLE AND PATIENT GOT A FEW STITCHES. 2 CARTRIDGES OF SEPTOCAINE 1:200,000 WERE USED FOR THE PROCEDURE. DURING THE 2ND CARTRIDGE, THE NEEDLE BROKE. THE DENTIST MENTIONED NEEDLE WAS NOT INSERTED TO HUB DURING INJECTION. THE PATIENT DID NOT HAVE SUDDEN MOVEMENT NOR ANXIOUS NOR EXTREME PRESSURE WAS NEEDED ACCORDING TO THE DENTIST. THE NEEDLE WAS NOT BENT. THE DENTIST MENTIONED REGARDING THE CARE PROTOCOL THAT ROUTINE DENTAL PROTOCOL WAS CARRIED OUT AS CORRECTIVE TREATMENT. OUTCOME: AT THE TIME OF THE REPORT, THE PATIENT'S OUTCOME WAS UNKNOWN. OTHER INFORMATION OF PRODUCT: DARBY PLASTIC HUB NEEDLE 30GA SHORT, BATCH NUMBER: #F13378AA, EXPIRY DATE: UNKNOWN. SEPTOCAINE 1:200,000, BATCH NUMBER: UNKNOWN, EXPIRY DATE: UNKNOWN. NO OTHER INFORMATION AVAILABLE. THIS CASE WAS CONSIDERED AS SERIOUS DUE TO REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES). FOLLOW-UP #1: RECEIVED ADDITIONAL INFORMATION REGARDING PATIENT DETAILS, PROCEDURE DETAILS, ANESTHETIC DETAILS, AND INCIDENT DESCRIPTION. MANUFACTURER'S PRELIMINARY COMMENTS: BASED ON THE FIRST INFORMATION AVAILABLE, THE REPORT DESCRIBED NEEDLE BROKEN (AT HUB) AND DEVICE FRAGMENT EMBEDDED WITH THE SUSPECTED MEDICAL DEVICE DARBY PLASTIC HUB NEEDLE 30GA SHORT PRIOR TO ROOT CANAL OF TOOTH NUMBER 30, ON A FEMALE PATIENT WHO WAS APPROXIMATELY 40 YEARS OLD WITH AN UNSPECIFIED MEDICAL HISTORY. THE DOCTOR HAD TO SEND THE PATIENT TO ORAL AND MAXILLOFACIAL SURGEON (OMFS) FOR REMOVAL AS NEEDLE BROKE IN THEIR MOUTH. OMFS REMOVED THE NEEDLE AND PATIENT GOT A FEW STITCHES. THE PATIENT DID NOT HAVE SUDDEN MOVEMENT NOR ANXIOUS NOR EXTREME PRESSURE WAS NEEDED ACCORDING TO THE DENTIST. THE NEEDLE WAS NOT BENT. IN ADDITION, THE DENTIST MENTIONED NEEDLE WAS NOT INSERTED TO HUB DURING INJECTION. CAUSES OF NEEDLE BREAKAGE MAY INCLUDE BENDING OF NEEDLE PRIOR USE, INSERTION UP TO THE HUB, EXCESSIVE PRESSURE OR MOVEMENT OF THE NEEDLE DURING INJECTION, A SUDDEN MOVEMENT OF THE PATIENT DURING INJECTION AND/OR THE USE OF A NEEDLE SIZE INAPPROPRIATE TO THE TYPE OF PROCEDURE, OR THE USE OF THE NEEDLE IN SPITE OF AN OBSTACLE (E.G BONE). ACCORDING TO THE INFORMATION REPORTED, MISHANDLING OR MISUSE DOESN'T SEEM TO BE SUSPECTED, HOWEVER PENDING QUALITY INVESTIGATIONS AND FURTHER DETAILS, NO ROOT CAUSE COULD BE DETERMINED FOR THIS INCIDENT. USE ERROR/ABNORMAL USE CANNOT BE EXCLUDED EITHER. #FU1 CONSIDERED. BASED ON THE PRELIMINARY ANALYSIS, PENDING QUALITY INVESTIGATION, NO CAPA IS REQUIRED.
MFR REPORT #: (B)(4). #1: NEEDLE BROKEN V28.0 (NEEDLES BREAKING AT HUB): FROM TO - SERIOUS - UNKNOWN. #2: DEVICE FRAGMENT EMBEDDED V28.0 (HAD TO SEND PATIENT TO OMFS FOR REMOVAL AS NEEDLE BROKE IN THEIR MOUTH. OMFS REMOVED THE NEEDLE AND PATIENT GOT A FEW STITCHES): FROM TO - 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 10-JUL-2025 FROM DENTIST BY EMAIL VIA DISTRIBUTOR. FOLLOW-UP #1 WAS RECEIVED ON 21-JUL-2025 FROM DENTIST VIA PHONE CALL. FOLLOW-UP #2 WAS RECEIVED ON 23-JUL-2025 FROM THE QUALITY DEPARTMENT. ALL THE INFORMATION WAS PROCESSED TOGETHER. THE REPORT DESCRIBED NEEDLE BROKEN AND DEVICE FRAGMENT EMBEDDED WITH THE SUSPECTED MEDICAL DEVICE DARBY PLASTIC HUB NEEDLE 30GA SHORT PRIOR TO ROOT CANAL OF TOOTH NUMBER 30. THIS CASE OCCURRED ON A FEMALE PATIENT WHO WAS APPROXIMATELY 40 YEARS OLD WITH AN UNSPECIFIED MEDICAL HISTORY. NO ADDITIONAL INFORMATION WAS AVAILABLE ON THE PATIENT. ON AN UNSPECIFIED DATE, IT WAS REPORTED THAT THE NEEDLE BROKE AT THE HUB. THE NEEDLE WAS DEEPLY EMBEDDED IN THE PATIENT'S GUM. THE DOCTOR HAD TO SEND THE PATIENT TO ORAL AND MAXILLOFACIAL SURGEON (OMFS) FOR REMOVAL AS NEEDLE BROKE IN THEIR MOUTH. OMFS REMOVED THE NEEDLE AND PATIENT GOT A FEW STITCHES. 2 CARTRIDGES OF SEPTOCAINE 1:200,000 WERE USED FOR THE PROCEDURE. DURING THE 2ND CARTRIDGE, THE NEEDLE BROKE. THE DENTIST MENTIONED NEEDLE WAS NOT INSERTED TO HUB DURING INJECTION. THE PATIENT DID NOT HAVE SUDDEN MOVEMENT NOR ANXIOUS NOR EXTREME PRESSURE WAS NEEDED ACCORDING TO THE DENTIST. THE NEEDLE WAS NOT BENT. THE DENTIST MENTIONED REGARDING THE CARE PROTOCOL THAT ROUTINE DENTAL PROTOCOL WAS CARRIED OUT AS CORRECTIVE TREATMENT. OUTCOME: AT THE TIME OF THE REPORT, THE PATIENT'S OUTCOME WAS UNKNOWN. OTHER INFORMATION OF PRODUCT: DARBY PLASTIC HUB NEEDLE 30GA SHORT, BATCH NUMBER: #F13378AA, EXPIRY DATE: UNKNOWN. SEPTOCAINE 1:200,000, BATCH NUMBER: UNKNOWN, EXPIRY DATE: UNKNOWN. NO OTHER INFORMATION AVAILABLE. ------- THIS CASE WAS CONSIDERED AS SERIOUS DUE TO REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES). ============ FOLLOW-UP #1: RECEIVED ADDITIONAL INFORMATION REGARDING PATIENT DETAILS, PROCEDURE DETAILS, ANESTHETIC DETAILS, AND INCIDENT DESCRIPTION. FOLLOW-UP #2: RECEIVED QIR. ----------------------------------------------------- MANUFACTURER'S PRELIMINARY COMMENTS: BASED ON THE FIRST INFORMATION AVAILABLE, THE REPORT DESCRIBED NEEDLE BROKEN (AT HUB) AND DEVICE FRAGMENT EMBEDDED WITH THE SUSPECTED MEDICAL DEVICE DARBY PLASTIC HUB NEEDLE 30GA SHORT PRIOR TO ROOT CANAL OF TOOTH NUMBER 30, ON A FEMALE PATIENT WHO WAS APPROXIMATELY 40 YEARS OLD WITH AN UNSPECIFIED MEDICAL HISTORY. THE DOCTOR HAD TO SEND THE PATIENT TO ORAL AND MAXILLOFACIAL SURGEON (OMFS) FOR REMOVAL AS NEEDLE BROKE IN THEIR MOUTH. OMFS REMOVED THE NEEDLE AND PATIENT GOT A FEW STITCHES. THE PATIENT DID NOT HAVE SUDDEN MOVEMENT NOR ANXIOUS NOR EXTREME PRESSURE WAS NEEDED ACCORDING TO THE DENTIST. THE NEEDLE WAS NOT BENT. IN ADDITION, THE DENTIST MENTIONED NEEDLE WAS NOT INSERTED TO HUB DURING INJECTION. CAUSES OF NEEDLE BREAKAGE MAY INCLUDE BENDING OF NEEDLE PRIOR USE, INSERTION UP TO THE HUB, EXCESSIVE PRESSURE OR MOVEMENT OF THE NEEDLE DURING INJECTION, A SUDDEN MOVEMENT OF THE PATIENT DURING INJECTION AND/OR THE USE OF A NEEDLE SIZE INAPPROPRIATE TO THE TYPE OF PROCEDURE, OR THE USE OF THE NEEDLE IN SPITE OF AN OBSTACLE (E.G BONE). ACCORDING TO THE INFORMATION REPORTED, MISHANDLING OR MISUSE DOESN'T SEEM TO BE SUSPECTED, HOWEVER PENDING QUALITY INVESTIGATIONS AND FURTHER DETAILS, NO ROOT CAUSE COULD BE DETERMINED FOR THIS INCIDENT. USE ERROR/ABNORMAL USE CANNOT BE EXCLUDED EITHER. #FU1 CONSIDERED. BASED ON THE PRELIMINARY ANALYSIS, PENDING QUALITY INVESTIGATION, NO CAPA IS REQUIRED. FOR FINAL (REPORTABLE INCIDENT): DESCRIPTION OF THE MANUFACTURER¿S EVALUATION CONCERNING POSSIBLE ROOT CAUSES/CAUSATIVE FACTORS AND CONCLUSION: 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. THE USED CANNULAS WERE RECEIVED WITH A CERTIFICATE OF CONFORMITY FROM SUPPLIER. MANY FACTORS COULD LEAD TO THE REPORTED ISSUE CANNULA BREAKAGE, SUCH AS: HIGH PRESSURE DURING INJECTION, CONSTRAINT ON THE CANNULA DURING INJECTION, UNEXPECTED MOVEMENT DURING INJECTION, USE OF SEVERAL CARTRIDGES WITH THE SAME NEEDLE (MULTIPLE NEEDLE USE), BENDING OR STRESSING OF THE CANNULA, USE OF NEEDLE NOT RECOMMENDED ACCORDING TO THE INJECTION TYPE, INJECTION ON A HARD SURFACE. THE DENTIST MENTIONED THAT THE NEEDLE WAS NOT INSERTED ALL THE WAY TO THE HUB DURING THE INJECTION, THAT THE PATIENT DID NOT EXPERIENCE ANY SUDDEN MOVEMENTS OR ANXIETY, THAT NO EXTREME PRESSURE WAS REQUIRED, AND THAT THE NEEDLE WAS NOT BENT. HOWEVER, HE CONFIRMED THAT THE BREAKAGE OCCURRED AFTER USING THIS NEEDLE FOR THE INJECTION OF A SECOND CARTRIDGE OF ANAESTHETIC. THE NEEDLES ARE FOR SINGLE USE ONLY; USING THE SAME NEEDLE FOR MULTIPLE INJECTIONS (MULTIPLE CARTRIDGES) CAN WEAKEN THE CANNULA AND CAUSE THE BREAKAGE OBSERVED. USE ERROR/ABNORMAL USE CONCLUDED. RESULTS OF THE ASSESSMENT: IN THE RISK TABLE AR028.02, THIS RISK IS COVERED UNDER THE HAZARD ID USE-SOFIJ3-016 HAZARD DEVICE USIGN. THIS IS THE FIRST COMPLAINT FOR THE CLAIMED BATCH F13378AA REGARDING THE TOTAL QUANTITY SOLD ((B)(4) NEEDLES). THE OCCURRENCE IS EVALUATED AS LOW. BASED ON THE INVESTIGATION PERFORMED WE EVALUATE THE RESIDUAL RISK AS ACCEPTABLE. DESCRIPTION OF REMEDIAL ACTION/CORRECTIVE ACTION/PREVENTIVE ACTION/FIELD SAFETY CORRECTIVE ACTION (FSCA): SINCE THE ROOT CAUSE IS UNDETERMINED AND THE OCCURRENCE OF THE REPORTED ISSUE IS LOW, NO SPECIFIC CORRECTIVE ACTION WILL BE IMPLEMENTED. FINAL COMMENTS FROM THE MANUFACTURER: NO QUALITY ISSUE IDENTIFIED. USE ERROR/ABNORMAL USE CONCLUDED. NO CAPA IMPLEMENTED.
MFR REPORT #: (B)(4). #1: NEEDLE BROKEN V28.0 (NEEDLES BREAKING AT HUB): FROM TO - SERIOUS #2: DEVICE FRAGMENT EMBEDDED V28.0 (HAD TO SEND PATIENT TO OMFS FOR REMOVAL AS NEEDLE BROKE IN THEIR MOUTH. OMFS REMOVED THE NEEDLE AND PATIENT GOT A FEW STITCHES): FROM TO - 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 10-JUL-2025 FROM DENTIST BY EMAIL VIA DISTRIBUTOR. THE REPORT DESCRIBED NEEDLE BROKEN AND DEVICE FRAGMENT EMBEDDED WITH THE SUSPECTED MEDICAL DEVICE DARBY PLASTIC HUB NEEDLE 30GA SHORT PRIOR TO AN UNSPECIFIED PROCEDURE. THIS CASE OCCURRED ON A PATIENT OF UNSPECIFIED AGE, SEX AND MEDICAL HISTORY. NO ADDITIONAL INFORMATION WAS AVAILABLE ON THE PATIENT. ON AN UNSPECIFIED DATE, IT WAS REPORTED THAT THE NEEDLE BROKE AT HUB. THE DOCTOR HAD TO SEND THE PATIENT TO ORAL AND MAXILLOFACIAL SURGEON (OMFS) FOR REMOVAL AS NEEDLE BROKE IN THEIR MOUTH. OMFS REMOVED THE NEEDLE AND PATIENT GOT A FEW STITCHES. OUTCOME: AT THE TIME OF THE REPORT, THE PATIENT'S OUTCOME WAS UNKNOWN. OTHER INFORMATION OF PRODUCT: DARBY PLASTIC HUB NEEDLE 30GA SHORT, BATCH NUMBER: #F13378AA, EXPIRY DATE: UNKNOWN. THIS CASE WAS CONSIDERED AS SERIOUS DUE TO REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES). NO OTHER INFORMATION AVAILABLE. MANUFACTURER'S PRELIMINARY COMMENTS: BASED ON THE FIRST INFORMATION AVAILABLE, THE REPORT DESCRIBED NEEDLE BROKEN (AT HUB) AND DEVICE FRAGMENT EMBEDDED WITH THE SUSPECTED MEDICAL DEVICE DARBY PLASTIC HUB NEEDLE 30GA SHORT PRIOR TO AN UNSPECIFIED PROCEDURE ON A PATIENT OF UNSPECIFIED AGE, SEX AND MEDICAL HISTORY. THE DOCTOR HAD TO SEND THE PATIENT TO ORAL AND MAXILLOFACIAL SURGEON (OMFS) FOR REMOVAL AS NEEDLE BROKE IN THEIR MOUTH. OMFS REMOVED THE NEEDLE AND PATIENT GOT A FEW STITCHES. CAUSES OF NEEDLE BREAKAGE MAY INCLUDE BENDING OF NEEDLE PRIOR USE, INSERTION UP TO THE HUB, EXCESSIVE PRESSURE OR MOVEMENT OF THE NEEDLE DURING INJECTION, A SUDDEN MOVEMENT OF THE PATIENT DURING INJECTION AND/OR THE USE OF A NEEDLE SIZE INAPPROPRIATE TO THE TYPE OF PROCEDURE, OR THE USE OF THE NEEDLE IN SPITE OF AN OBSTACLE (E.G BONE). HOWEVER, THERE WAS FEW INFORMATION ABOUT THE TYPE OF ANAESTHESIA OR INJECTION COURSE IN THIS REPORT TO CONCLUDE. THEREFORE, PENDING QUALITY INVESTIGATIONS, NO ROOT CAUSE COULD BE DETERMINED FOR THIS INCIDENT. USE ERROR/ABNORMAL USE CANNOT BE EXCLUDED. BASED ON THE PRELIMINARY ANALYSIS, PENDING QUALITY INVESTIGATION, NO CAPA IS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 821654 | DARBY PLASTIC HUB NEEDLE 30GA SHORT | NEEDLE, DENTAL | DZM | SOFIC | F13378AA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Female | Required Intervention |